Monitoring methods using holistic data concepts

Abstract

A method including obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period, obtaining second data, the second data being data based on impedance measurements from inside the human during a second temporal period and clinically interpreting the second data based at least in part on the first data as a historical baseline.

Description

MONITORING METHODS USING HOLISTIC DATA CONCEPTSCROSS-REFERENCE TO RELATED APPLICATIONS[oooi] This application claims priority to U.S. Provisional Application No. 63 / 617,924, entitled MONITORING METHODS USING HOLISTIC DATA CONCEPTS, filed on January 5, 2024, naming Wolfram Frederik DUECK as an inventor, the entire contents of that application being incorporated herein by reference in its entirety.BACKGROUND

[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components / devices, external or wearable components / devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and / or lifestyle enhancement functions and / or recipient monitoring for a number of years.

[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease / injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and / or data received from external devices that are part of, or operate in conjunction with, implantable components.SUMMARY

[0004] In accordance with an exemplary embodiment, there is a method, comprising obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period, obtaining second data, the second data being data based on impedance measurements from inside the human during a second temporal period andclinically interpreting the second data based at least in part on the first data as a historical baseline.

[0005] In an embodiment, there is method, comprising obtaining first data, the first data including impedance measurements from inside a human during a first temporal period, obtaining second data, the second data including stimulation history of one or more electrodes of an implanted medical device for second temporal period before the first temporal period and evaluating the first data based at least in part on the second data.

[0006] In an embodiment, there is a system, comprising an input subsystem configured to receive input regarding impedance values inside a person who has received a medical device, a memory, an output subsystem and at least one of (i) a data evaluation subsystem in signal communication with the input subsystem and the output subsystem and the memory, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input or (ii) a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the input subsystem and the output subsystem are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system.

[0007] In an embodiment, there is a method, comprising obtaining first data based on at least one variable of charge transfer data of electrode(s) implanted in a human, obtaining second data based on at least one impedance measurement taken with the electrode(s) and at least one of developing a correlation between the first data and the second data or validating and / or invalidating and / or calibrating the second data based at least in part on the first data.

[0008] In an embodiment, there is a non-transitory computer readable medium, comprising code for obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period, code for obtaining second data, the second data being data based on one or more state conditions and code for automatically clinically interpreting the first data based at least in part on the second data.

[0009] In an embodiment, there is a system, comprising a GUI and / or a USB and / or wired receiver and / or wireless receiver that receives receive input regarding impedance values inside a person who has received a medical device a computational device memory and atleast one of (i) a data evaluation subsystem in signal communication with the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and the, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input and output data indicative of the comparison or (ii) a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and / or a second GUI and / or a second USB and / or a wired transmitter and / or a wireless transmitter are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system.BRIEF DESCRIPTION OF THE DRAWINGS[ooio] Embodiments are described below with reference to the attached drawings, in which:

[0011] FIG. 1A is a perspective view of an exemplary hearing prosthesis in which at least some of the teachings detailed herein are applicable;

[0012] FIG. IB depicts a side view of the cochlear implant 100 outside of the recipient;

[0013] FIG. 1C depicts a vestibular implant;

[0014] FIG. 2 is side view of an insertion guide for implanting a cochlear implant electrode assembly such as the electrode assembly illustrated in FIG. 1;

[0015] FIGs. 3 A and 3B are side and perspective views of an electrode assembly extended out of an embodiment of an insertion sheath of the insertion guide illustrated in FIG. 2;

[0016] FIGs. 4A-4E are simplified side views depicting the position and orientation of a cochlear implant electrode assembly insertion guide tube relative to the cochlea at each of a series of successive moments during an exemplary implantation of the electrode assembly into the cochlea;

[0017] FIGs. 5-9 are exemplary system components of an exemplary embodiment;

[0018] FIG. 10 depicts an exemplary four point impedance measurement;

[0019] FIGs. 11-17 present exemplary algorithms for exemplary methods; and

[0020] FIG. 18 presents an exemplary functional block diagram for an exemplary system.DETAILED DESCRIPTION

[0021] Merely for ease of description, the techniques presented herein are described herein with reference by way of background to an illustrative medical device, namely a cochlear implant. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from setting changes based on the location of the medical device. For example, the techniques presented herein may be used to determine the viability of various types of prostheses, such as, for example, a vestibular implant, with respect to a particular human being. Any reference to one of the above-noted sensory prostheses corresponds to an alternate disclosure using one of the other above-noted sensory prostheses unless otherwise noted, providing that the art enables such.

[0022] FIG. 1A is a perspective view of a cochlear implant, referred to as cochlear implant 100, implanted in a recipient, to which some embodiments detailed herein and / or variations thereof are applicable. The cochlear implant 100 is part of a system 10 that can include external components in some embodiments, as will be detailed below. It is noted that the teachings detailed herein are also applicable to so-called multi-mode devices. In an exemplary embodiment, these multi-mode devices apply both electrical stimulation and acoustic stimulation to the recipient. In an exemplary embodiment, these multi-mode devices evoke a hearing percept via electrical hearing and bone conduction hearing. Accordingly, any disclosure herein with regard to one of these types of hearing prostheses corresponds to a disclosure of another of these types of hearing prostheses or any medical device for that matter, unless otherwise specified, or unless the disclosure thereof is incompatible with a given device based on the current state of technology.

[0023] In view of the above, it is to be understood that at least some embodiments detailed herein and / or variations thereof are directed towards a body-worn sensory supplement medical device (e.g., the hearing prosthesis of FIG. 1A, which supplements the hearing sense, even in instances when there are no natural hearing capabilities, for example, due to degeneration of previous natural hearing capability or to the lack of any natural hearing capability, for example, from birth).

[0024] The recipient has an outer ear 101, a middle ear 105, and an inner ear 107. Components of outer ear 101, middle ear 105, and inner ear 107 are described below, followed by a description of cochlear implant 100.

[0025] In a fully functional ear, outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102. Disposed across the distal end of ear channel 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111. Bones 108, 109, and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to vibration of tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside of cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.

[0026] As shown, cochlear implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient. Cochlear implant 100 is shown in FIG. 1 with an external device 142, that is part of system 10 (along with cochlear implant 100), which, as described below, is configured to provide power to the cochlear implant, where the implanted cochlear implant includes a battery that is rechargeable via the transcutaneous link.

[0027] In the illustrative arrangement of FIG. 1A, external device 142 can comprise a power source (not shown) disposed in a Behind-The-Ear (BTE) unit 126. External device 142 also includes components of a transcutaneous energy transfer link, referred to as an external energy transfer assembly. The transcutaneous energy transfer link is used to transfer power and / or data to cochlear implant 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive and inductive transfer, may be used to transfer the power and / or data from external device 142 to cochlear implant 100. In the illustrative embodiments of FIG. 1, the external energy transfer assembly comprises an external coil 130 that forms part of an inductive radio frequency (RF) communication link. External coil 130 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multistrand platinum or gold wire. External device 142 also includes a magnet (not shown) positioned within the turns of wire of external coil 130. It should be appreciated that the external device shown in FIG. 1 is merely illustrative, and other external devices may be used with embodiments of the present invention.

[0028] Cochlear implant 100 comprises an internal energy transfer assembly 132 which can be positioned in a recess of the temporal bone adjacent auricle 110 of the recipient. As detailed below, internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and / or data from external device 142. In the illustrative embodiment, the energy transfer link comprises an inductive RF link, and internal energy transfer assembly 132 comprises a primary internal coil 136. Internal coil 136 is typically a wire antenna coil comprised of multiple turns of electrically insulated singlestrand or multi-strand platinum or gold wire.

[0029] Cochlear implant 100 further comprises a main implantable component 120 and an elongate electrode assembly 118. In some embodiments, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, main implantable component 120 includes an implantable microphone assembly (not shown) and a sound processing unit (not shown) to convert the sound signals received by the implantable microphone in internal energy transfer assembly 132 to data signals. That said, in some alternative embodiments, the implantable microphone assembly can be located in a separate implantable component (e.g., that has its own housing assembly, etc.) that is in signal communication with the main implantable component 120 (e.g., via leads or the like between the separate implantable component and the main implantable component 120). In at least some embodiments, the teachings detailed herein and / or variations thereof can be utilized with any type of implantable microphone arrangement.

[0030] Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate electrode assembly 118.

[0031] Elongate electrode assembly 118 has a proximal end connected to main implantable component 120, and a distal end implanted in cochlea 140. Electrode assembly 118 extends from main implantable component 120 to cochlea 140 through mastoid bone 119. In some embodiments, electrode assembly 118 may be implanted at least in basal region 116, and sometimes further. For example, electrode assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, electrode assembly 118 may be inserted into cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through round window 121, oval window 112, the promontory 123 or through an apical turn 147 of cochlea 140.

[0032] Electrode assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, disposed along a length thereof. As noted, a stimulator unit generates stimulation signals which are applied by electrodes 148 to cochlea 140, thereby stimulating auditory nerve 114.

[0033] FIG. IB is a side view of a cochlear implant 100 without the other components of system 10 (e.g., the external components). Cochlear implant 100 comprises a receiver / stimulator 180 and an electrode assembly or lead 118. Electrode assembly 118 includes a helix region 182, a transition region 184, a proximal region 186, and an intra- cochlear region 188. Proximal region 186 and intra-cochlear region 188 form an electrode array assembly 190. In an exemplary embodiment, proximal region 186 is located in the middle-ear cavity of the recipient after implantation of the intra-cochlear region 188 into the cochlea. Thus, proximal region 186 corresponds to a middle-ear cavity sub-section of the electrode array assembly 190. Electrode array assembly 190, and in particular, intra-cochlear region 188 of electrode array assembly 190, supports a plurality of electrode contacts 148. These electrode contacts 148 are each connected to a respective conductive pathway, such as wires, PCB traces, etc. (not shown) which are connected through lead 118 to receiver / stimulator 180, through which respective stimulating electrical signals for each electrode contact 148 travel.

[0034] Electrode array 146 may be inserted into cochlea 140 with the use of an insertion guide. It is noted that while the embodiments detailed herein are described in terms of utilizing an insertion guide or other type of tool to guide the array into the cochlea, in some alternate insertion embodiments, a tool is not utilized. Instead, the surgeon utilizes his or her fingertips or the like to insert the electrode array into the cochlea. That said, in some embodiments, alternate types of tools can be utilized other than and / or in addition to insertion guides. By way of example only and not by way of limitation, surgical tweezers like can be utilized. Any device, system, and / or method of inserting the electrode array into the cochlea can be utilized according to at least some exemplary embodiments.

[0035] Figure 1C depicts an exemplary vestibular implant 500 according to one example. Some specific features are described utilizing the above-noted cochlear implant of figure 1A in the context of a vestibular implant. In this regard, some features of a cochlear implant are utilized with vestibular implants. In the interest of textual and pictorial economy, various elements of the vestibular implant that generally correspond to the elements of the cochlear implant above are referenced utilizing the same numerals. Still, it is noted that some featuresof the vestibular implant 500 will be different from that of the cochlear implant above. By way of example only and not by way of limitation, there may not be a microphone on the behind-the-ear device 126. Alternatively, sensors that have utilitarian value in the vestibular implant can be contained in the BTE device 126. By way of example only and not by way of limitation, motion sensors can be located in BTE device 126. There also may not be a sound processor in the BTE device. Conversely, other types of processors, such as those that process data obtained from the sensors, will be present in the BTE device 126. Power sources, such as a battery, will also be included in the BTE device 126. Consistent with the BTE device of the cochlear implant of figure 1, a transmitter / transceiver will be located in the BTE device or otherwise in signal communication therewith.

[0036] Embodiments also include application of the teachings herein with respect to a retinal prosthesis / bionic eye, such as that disclosed in PCT Patent Application PCT / IB2023 / 055304, entitled Transcutaneous Power Transfer and the electrodes of WO 2022 / 130287.

[0037] The implantable component includes a receiver stimulator in a manner concomitant with the above cochlear implant. Here, vestibular stimulator comprises a main implantable component 120 and an elongate electrode assembly 1188 (where the elongate electrode assembly 1188 has some different features from the elongate electrode assembly 118 of the cochlear implant, some of which will be described shortly). In some embodiments, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, main implantable component 120 includes a processing unit (not shown) to convert data obtained by sensors, which could be on board sensors implanted in the recipient, into data signals.

[0038] Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate electrode assembly 1188.

[0039] It is briefly noted that while the embodiment shown in figure 1C represents a partially implantable vestibular implant, embodiments can include a totally implantable vestibular implant, such as, where, for example, the motion sensors are located in the implantable portion, in a manner analogous to a cochlear implant.

[0040] Elongate electrode assembly 1188 has a proximal end connected to main implantable component 120, and extends through a hole in the mastoid 119, in a manner analogous to theelongate electrode assembly 118 of the cochlear implant, and includes a distal end that extends to the inner ear. In some embodiments, the distal portion of the electrode assembly 1188 includes a plurality of leads 510 that branch out away from the main body of the electrode assembly 118 to electrodes 520. Electrodes 520 can be placed at the base of the semicircular ducts as shown in figure 5. In an exemplary embodiment, one or more of these electrodes are placed in the vicinity of the vestibular nerve branches innervating the semicircular canals. In some embodiments, the electrodes are located external to the inner ear, while in other embodiments, the electrodes are inserted into the inner ear. Note also while this embodiment does not include an electrode array located in the cochlea, in other embodiments, one or more electrodes are located in the cochlea in a manner analogous to that of a cochlear implant.

[0041] The teachings detailed herein are directed towards identifying phenomenon inside a cochlea (or inside a semi-circular canal / vestibula - the teachings herein can be applicable to an electrode array or an electrode that has been implanted in a semi-circular canal in some scenarios - any disclosure of a cochlea, a cochlear implant, or a cochlear implant electrode array corresponds to an alternate disclosure of a semi-circular canal / vestibula, a vestibular implant or a vestibular implant electrode / electrode array - these are not the same - we are simply using this manner to describe the features in the interests of textual economy).

[0042] Some embodiments include obtaining voltage measurements from inside and / or outside the cochlea and analyzing them in, by way of example only and not by way of limitation, an automated manner, by comparing the voltage measurements to statistical data.

[0043] FIG. 2A presents a side view of an embodiment of an insertion guide for implanting an elongate electrode assembly generally represented by electrode assembly 145 (corresponding to assembly 190 of FIG. IB) into a mammalian cochlea, represented by cochlea 140. The illustrative insertion guide, referred to herein as insertion guide 200, includes an elongate insertion guide tube 210 configured to be inserted into cochlea 140 and having a distal end 212 from which an electrode assembly is deployed. Insertion guide tube 210 has a radially-extending stop 204 that may be utilized to determine or otherwise control the depth to which insertion guide tube 210 is inserted into cochlea 140.

[0044] Insertion guide tube 210 is mounted on a distal region of an elongate staging section 208 on which the electrode assembly is positioned prior to implantation. A robotic arm adapter 202 is mounted to a proximal end of staging section 208 to facilitate attachment ofthe guide to a robot, which adapter includes through holes 203 through which bolts can be passed so as to bolt the guide 200 to a robotic arm, as will be detailed below.

[0045] FIGs. 3A and 3B are side and perspective views, respectively, of representative electrode assembly 145. As noted, electrode assembly 145 comprises an electrode array 146 of electrode contacts 148. Electrode assembly 145 is configured to place electrode contacts 148 in close proximity to the ganglion cells in the modiolus. Such an electrode assembly, commonly referred to as a perimodiolar electrode assembly, is manufactured in a curved configuration as depicted in FIGS. 3A and 3B.

[0046] FIGs. 4A-4E are a series of side-views showing consecutive exemplary events that occur in an exemplary implantation of electrode assembly 145 into cochlea 140. Initially, electrode assembly 145 and insertion guide tube 310 are assembled. For example, electrode assembly 145 is inserted (slidingly or otherwise) into a lumen of insertion guide tube 300. The combined arrangement is then inserted to a predetermined depth into cochlea 140, as illustrated in FIG. 4 A. Typically, such an introduction to cochlea 140 is achieved via cochleostomy 122 (FIG. 1) or through round window 121 or oval window 112. As shown in FIGs. 4B-4D, electrode assembly 145 may be continually advanced through insertion guide tube 300 while the insertion sheath is maintained in a substantially stationary position. Once electrode assembly 145 is located at the desired depth in the scala tympani, insertion guide tube 300 is removed from cochlea 140 while electrode assembly 145 is maintained in a stationary position. This is illustrated in FIG. 4E.

[0047] As can be recognized from the above, the electrode array can be utilized to obtain the data utilized in the methods herein, such as by way of example only and not by way of limitation, the voltages at the read electrodes, and can also be used to provide the stimulating electrode (just in case for some reason that was not clear). FIG. 5 depicts an exemplary system for utilizing the cochlear implant to obtain such information. Presented in functional terms, there is a test unit 3960 in signal communication with unit 8310, which in turn is in signal communication, optionally with a unit 7720 and a unit 8320, the details of which will be described below.

[0048] Unit 3960 can correspond to an implantable component of an electrode array, as seen in FIG. 1. More specifically, FIG. 6 depicts an exemplary high-level diagram of a receiver / stimulator 8710 (the implantable portion of 100) of a cochlear implant, looking downward. As can be seen, the receiver / stimulator 8710 includes a magnet 160 that issurrounded by a coil 137 that is in two-way communication (although in other embodiments, the communication is one-way) with a stimulator unit 122, which in turn is in communication with the electrode array 145. Receiver / stimulator 8710 further includes a cochlear stimulator unit 122, in signal communication with the coil 137. The coil 137 and the stimulator unit 122 are encased in silicon as represented by element 199. In an exemplary embodiment, receiver / stimulator 8710 is utilized as test unit 3960, and is used to acquire information about electrode array position.

[0049] FIG. 8 depicts an exemplary RS (receiver / stimulator) interface 7444 which is presented by way of concept. An inductance coil 7410 is configured to establish a magnetic inductance field so as to communicate with the corresponding coil of the receiver-stimulator of the cochlear implant. Interface 7444 includes a magnet 7474 so as to hold the inductance coil 7410 against the coil of the receiver / stimulator of the cochlear implant in a manner analogous to how the external component of the cochlear implant is held against the implanted component, and how the coils of those respective components are aligned with one another. As can be seen, an electrical lead extends from the coil 7410 to control unit 8310, representing signal communication between interface 7444, and control unit 8310. It is noted that in an alternative embodiment, 7444 can be the external component of FIG. 1, and can have some and / or all of the functionalities just described, such that data can be obtained from the implanted portion outside of a clinical setting, such as during everyday life of the recipient.

[0050] FIG. 9 depicts an exemplary embodiment of the receiver / stimulator 8710 in signal communication with the control unit 8310 via electrical lead that extends from the interface device 7444 having coil 7410 about a magnet 7474 as can be seen. The interface device 7444 communicates via an inductance field with the inductance coil of the receiver / stimulator 8710 so that the data acquired by the implantable component 8710 (receiver / stimulator) can be transferred to the control unit 8310.

[0051] Note also that in at least some alternate exemplary embodiments, control unit 8310 can communicate with the so-called “hard ball” reference electrode of the implantable component of the cochlear implant so as to enable communication of data from the receiver / stimulator 8710 to control unit 8310 and / or vice versa.

[0052] It is noted that in the embodiment of FIG. 9, control unit 8310 is in signal communication with the various other components as detailed herein, which components are not depicted in FIG. 9 for purposes of clarity.

[0053] Also functionally depicted in FIG. 5 is the optional embodiment where an electrode array insertion robotic system / actuator system 7720 and an input device 8320 is included in the system. In an exemplary embodiment, the input device 8320 could be a trigger of a handheld device that controls the actuator system 7720 and can stop and / or start the actuator for insertion of the electrode array. In an exemplary embodiment, the input device 8320 could be a trigger on the tool 8200.

[0054] Control unit 8310 can be a signal processor or the like, or a personal computer or the like, or a mainframe computer or the like, etc., that is configured to receive signals from the test unit 3960 and analyze those signals to evaluate the data obtained (it can also be used to control the implant / control the application of current). More particularly, the control unit 8310 can be configured with software or the like to analyze the signals from test unit 3960 in real time and / or in near real time as the electrode array is being advanced into the cochlea by actuator assembly 7720 (if present, and if not present, while the array is being inserted / advanced by hand). The control unit 8310 analyzes the input from test unit 3960, after partial and / or full implantation and / or after the surgery is completed and / or as the electrode array advanced by the actuator assembly 7720 and / or as the electrode array is advanced by the surgeon by hand. The controller / control unit can be programmed to also control the stimulation / control the providing of current to the electrodes during the aforementioned events / situations. The controller 8310 can evaluate the input to determine if there exists a phenomenon according to the teachings detailed herein. The controller can evaluate telemetry, or otherwise receive telemetry, form the implant, via the device that communicates with the implant. That said, in an alternate embodiment, as depicted in FIG. 7, or in addition to this, the controller 8310 can output a signal to an optional monitor 9876 or other output device (e.g., buzzer, light, etc.), that can provide the surgeon or other healthcare professional performing the operation or evaluating the data postoperatively, etc., indicative of the data obtained and / or indicative of a conclusion reached by the control unit 8310. Note also that in an exemplary embodiment, the control unit 8310 can be a dumb unit in the sense that it simply passes along signals to the implant (e.g., the control unit can instead be a series of, for example, buttons where a surgeon depression is one button to provide stimulation to a given electrode). The control unit 8310 can be an external component of the cochlear implant.

[0055] Still, in some embodiments, the control unit 8310 is configured or otherwise programmed to evaluate input and determine if the input indicates that the electrode array is positioned in a given manner were otherwise that the electrode array is positioned in a manner different than that which was desired or otherwise determine any of the features detailed herein. In an exemplary embodiment, upon such a determination, control unit 8310 could halt the advancement of the array into the cochlea by stopping the actuator(s) of actuator assembly 7720 and / or could slow the actuator(s) so as to slow rate of advancement of the electrode array into the cochlea and / or could reverse the actuator(s) so as to reverse or otherwise retract the electrode array within the cochlea (either partially or fully). Alternatively, in embodiments where actuator assembly 7720 is not present, control unit 8310 could provide an indication to the surgeon or the like (via an integrated component, such as a buzzer or a light on the control unit, or an LDC screen, or via device 9876) to halt and / or slow the insertion, etc. In at least some exemplary embodiments, control unit 8310 can be configured to override the input from input unit 8320 input by the surgeon or the user.

[0056] Some exemplary embodiments utilize the receiver / stimulator 8710 as a test unit 3910 that enables the action of obtaining the data and the action of providing current to the electrode, and / or any one or more of the method actions detailed herein. In an exemplary embodiment, the receiver / stimulator 8710 and / or control unit 3810 and / or actuator assembly 7720 and / or input device 8320 are variously utilized to execute one or more or all of the method actions detailed herein, alone or in combination with an external component of a cochlear implant, and / or with the interface 7444, which can be used after the receiver / stimulator 8710 is fully implanted in the recipient and the incision to implant such has been closed (e.g., days, weeks, months or years after the initial implantation surgery). The interface 7444 can be used to control the receiver / stimulator to execute at least some of the method actions detailed herein (while in some other embodiments, the receiver / stimulator can execute such in an autonomous or semi-autonomous manner, without being in communication with an external component) and / or can be used to obtain data from the receiver / stimulator after execution of such method actions.

[0057] In view of the above, some embodiments include the utilization of, for example, one or more of the systems detailed above and / or below, to obtain electrode voltage measurements along the electrode array inserted into the cochlea. Some embodiments also include an analysis, such as an automatic analysis and / or semiautomatic analysis, such as by the systems detailed above, of the electrode voltages to determine one or more of the featuresherein / practice one or more of the method actions herein. Embodiments herein disclosed as using four point impedance measurements include using one or more of the devices above to execute such and to communicate the results to the outside and / or to a clinician or other healthcare professional. Any disclosure herein of implementing impedance tests includes a disclosure of using the above devices and using any one or more of the above noted devices’ functionalities. And in some embodiments, the above noted devices are configured to execute one or more of the method actions herein.

[0058] FIG. 10 shows an exemplary conceptual diagram of current flow between a source and a sink of an electrode array within the cochlea. Thus if the relative voltage is measured between ICE6 (ICE being intra-cochlear electrode - as distinguished from an electrode that is not in the cochlea, at least not when the measurement is executed) and ICE7, where electrodes 5 and 8 (ICE electrodes 5 and 8) are the stimulating electrodes (source and sink), in some exemplary scenarios, the voltage difference would be a certain value with respect to a cochlea at a certain condition and a cochlear at another condition.

[0059] Embodiments include a multi-contact cochlea electrode array, such as those detailed above, an implant with extra-cochlear electrodes (or another component, such as one that works in conjunction with the implanted portion of the cochlear implant, a receiver stimulator (such as that of the implanted portion), which can be either fully implanted or powered by an external behind the ear (BTE) processor or other external device. The implanted portion can include a built in-built amplifier configured to measure electrode voltages concurrent to the delivery of electrical current to either the same or adjacent electrode contacts.

[0060] In some instances, a method is executed whereby the implanted portion of the cochlear implant (e.g., receiver stimulator) or another device, such as the control unit detailed above, coordinates measurement electrode voltages in response to electrical stimulation to one or more contacts such that a measure of bulk impedance between two electrode contacts can be estimated.

[0061] Embodiments include using one or more sets of impedance measurements taken at specific temporal locations and / or separate temporal intervals, as latent variables to identify, or at least determine the plausibility, that one or more deleterious scenarios have occurred and / or will occur within the cochlea as a result of insertion of a cochlear implant electrode array therein, and to commence a treatment based on the impedance measurements. Conversely, embodiments include using one or more sets of impedance measurements takenat specific temporal locations and / or separate temporal intervals, as latent variables, to identify or at least determine the plausibility that one or more deleterious scenarios have not occurred, or otherwise that all is well within reason.

[0062] Embodiments include utilizing the impedance measurements to detect biomarkers (again, by way of latent variables in some embodiments) that are indicative of a change within a cochlea that will result in increased impedance between electrodes of a cochlear implant temporally downrange, which increase in impedance, if permitted to occur, is sufficiently high that the increase will have a deleterious effect on the operation of the cochlear implant (such as requiring an increase in power of the implant to evoke the same hearing percept as that which would be the case in the absence of the increase - in an embodiment, the increase in impedance can result in an increased load on the cochlear implant of at least 10, 15, 20, 25, or 30%, or any value or range of values therebetween in 1% increments above that which would otherwise be the case, all other things being equal) or otherwise that a deleterious effect is occurring within the human. Embodiments further include utilizing current / more temporally recent impedance measurements to determine impedance between at least two electrodes, in some embodiments, electrodes immediately adjacent to each other, and comparing such to historical data or otherwise using historical data to evaluate the current impedance measurements.

[0063] Methods include energizing one or more electrodes of a cochlear electrode array to induce a current flow in the cochlea at a plurality of temporal locations to execute four point impedance measurement. By way of example only and not by way of limitation, in an exemplary embodiment, this can include energizing electrode 9 and / or 12 (where 9 and 12 are alternatingly utilized as a source and sink when both are energized). Other electrode(s) can be energized.

[0064] Embodiments include measuring impedances regularly to monitor the status of cochlear implant recipients to confirm the integrity of the device and / or to gain insight into the nature of the electroneural interface. For example only and not by way of limitation, a rise in impedances could indicate growth in fibrous tissue around the electrode array. It is utilitarian to know this in at least some instances. Embodiments include scenarios where impedance measurements are highly variable, which can be depending on multiple factors. In accordance with teachings herein, impedances can be relatively high in the morning after a period of non-use of a cochlear implant (i.e., after sleeping, where the cochlear implant was not used at all and / or only for “alarm” purposes for the preceding at least 4 or 5 or 6, or 7 or 8hours by way of example or any value or range of values therebetween in 1 minute increments. Embodiments include scenarios where impedance(s) increase in comparison to a long-run baseline without understanding a root cause. These increases can persist for short periods (hours), or longer periods (days or months), or permanently.

[0065] Utilizing any one or more of the teachings herein can, in some embodiments, result in relative higher confidence for the clinician and / or patient through software assisted / computer assisted interpretation of clinical impedances measures, relative to that which would otherwise be the case in the absence of the teachings herein, all other things being equal. The teachings herein can render impedance as objective measure to assess the status quo and / or changes of the electrode array interface and / or biological environment adjacent to the electrodes, relative to that which would otherwise be the case in the absence of the teachings. Also, the teachings herein can enable impedance as a diagnostic measure for such things as, for example, early detection of inflammatory events and / or pathological foreign body reaction to allow informed intervention / prevention of things such as, loss of residual hearing and / or to protect cochlear health including the SGN population, and such can be improved upon relative to that which would otherwise be the case in the absence of the teachings detailed herein. Also, the teachings detailed herein can enable impedance as an objective measure to assess the effectiveness of a drug targeting inner ear related pathologies, such as, for example, suppression of inflammation, reduction of foreign body response, etc.

[0066] Embodiments include scenarios where traditional interpretation of the clinical significance of the absolute impedance, or change in impedance, or variation between different contacts on an electrode array, has been in prior evaluations, ad-hoc in clinical practice. By way of example, previously, the history of impedances of a specific recipient has not been understood or considered when interpreting impedances. Previously, impedances are measured at the start of a clinical review or mapping session and interpreted in isolation of earlier measurements not necessarily repeated with any plan in mind. Previously, there was no algorithm applied as to when to take an impedance measurement (in a rigorous manner) or how to interpret a specific measurement based on any history of impedance measures or other measurements, or clinical parameters. The teachings herein change this.

[0067] Embodiments include enabling clinicians to utilize the impedance data obtained using the above-noted devices and / or systems and / or methods to infer the integrity and / or status of the cochlear implant and the electroneural interface. A clinician can choose to look on past impedance measures and display graphs or tables of impedance measures from the past, andin embodiments, such measures are combined with other past measures such as stimulation levels or other diagnostic measures (for example ECochG or NRT). Embodiments include algorithms applied to assist with interpretation of the clinical significance of the measures. Embodiments thus go past / beyond merely measuring and report raw data separately on impedances and other measures and simply relying on clinicians make educated guesses as to the clinical significance of the data. Embodiment can enable clinicians or otherwise data analyzing professionals to gain a more comprehensive understanding of the state of the electroneural interface at a specific electrode or group of electrodes, and / or whether some clinical intervention should or should not be recommended or otherwise acted upon. Embodiments can also provide insight into the state of the tissue in the inner ear. The information / insight can be used to change (including optimize) simulation strategies and / or selection of medical therapy to treat inner ear conditions such as fibrosis or inflammation by way of example.

[0068] By recording the history of impedance measures and comparing a current measurement to past impedances, an analytical system can provide more valuable clinical insight than that which is currently available from a system that only presents raw data. The system can then provide information and / or analysis based on the historical context to support clinical interpretation. By adding data such as whether, when, and / or which electrode contacts have been stimulated in the history, the system can provide even greater understanding and insight into the status of the electroneural interface and the state of the tissue of the inner ear. This can be utilitarian in at least two exemplary scenarios: inexperienced clinicians who are not yet skilled enough to interpret complex cases; and also for more automated systems which can address the clinical needs in countries and situations where there is a limited resource of experienced clinicians to handle the increasing number of recipients.

[0069] By way of example, embodiments can include comparison with impedance and stimulation history in the period following surgery. In this regard, the period following surgery when the foreign body reaction occurs is a time in which the teachings can be applied herein. Monitoring impedances over time through this healing process can provide insight on whether the electroneural interface is trending to a normal / optimal state or at least a utilitarian state or an abnormal state which may require medical intervention or at least attention by a healthcare professional above that which would otherwise be the case (a cochlear implant recipient will receive attention even if all things are fine). For example, following surgery, ifimpedances change significantly, such as might be the case based on a number of factors as the tissue undergoes a normal healing process. The factors can include, for example, the insertion depth of the electrode array, whether the opening was a cochleostomy or round window, the time that has elapsed since surgery, how much and / or when stimulation has been applied and / or and whether the electrode array elutes dexamethasone.

[0070] Impedance of the basal electrode array contacts can rise over the weeks following surgery with tissue growth around the electrode array at the opening of the cochlea in some scenarios. A cochleostomy can generate bone growth which may give rise to higher levels of impedance compared to a round window insertion which tends to give rise to fibrous tissue growth. The increased impedance due to this healing process can be, for example, the highest at the most basal electrode(s) nearest to the opening and / or the apical end of the electrode. Embodiments thus include ascertaining knowledge of the insertion depth of the electrode and specifically whether the most basal electrodes are outside the cochlea, at the opening, or inside the inner ear by some distance, so as to utilize such information to interpret a rise in impedance following surgery. (Insertion depth of the electrode can be determined by electrophysiological measures which have / will be applied in future cochlear implant devices and / or intraoperative measurement systems.)

[0071] Embodiments include evaluating impedance changes, such as impedance rise, during and / or following periods of non-stimulation. Data-logs can be used in some embodiments to provide a record of which electrodes have been stimulated and / or have not been so stimulated, at what levels, and / or when. In embodiments, data logs can be stored in the implantable portion and / or the external portion (BTE or OTE device) and / or a clinic database, or cloud-based database. Scenarios include where the electrode array is a dexamethasoneeluting array that suppresses impedance rise.

[0072] Embodiments can take one or more of these factors into account when evaluating the impedance readings. More specifically, embodiments can draw one or more or all of the above information together, in a method and / or as part of a system, that applies an algorithm comparing the impedances of a particular patient / recipient against a normative database of a sufficiently large number of cases to confirm if the impedance levels following surgery for example are within normal bounds or outside of expectations, and thus needing more attention or specialist analysis to determine if some intervention is required. This can be utilitarian in cases of residual hearing where an excessive inflammatory reaction might compromise the preservation of hearing.

[0073] Embodiments include the utilization of additional information such as by way of example only and not by way of limitation, aetiology, co-morbidities, and / or non-hearing related drug regimes. These can add further to the ability of a system to provide insight from impedance measures. By way of example, a determination can be made that otosclerosis and / or a patient that has a relatively large vestibular aqueduct aetiologies, which can have different impedance profiles, which can be utilitarian to know when evaluating real-time impedances. Also, for example, whether a patient has diabetes and / or other diseases that impact electrolytes can be useful to take into account, which can impact impedances. Also, drug therapies such as growth hormone treatment can impact impedances. Embodiments thus include taking into account one or more of these phenomena when evaluating current / recent impedance values.

[0074] Embodiments also include measuring impedance values for a large number of patients and storing the resulting data in a database, which can be secure and / or proprietary. Embodiments can include applying machine learning and other artificial intelligence techniques to develop a more refined analysis of the clinical significance of impedance values / changes following surgery.

[0075] Embodiments also include comparison of impedances and other measures after an interior of a cochlea, for example, reaches a stable state (e.g., after healing / after tissue growth resulting from the initial trauma of implantation has run its course, etc.). After the cochlea has stabilized following surgery, whether that be weeks or months or longer after initial entry of the array into the cochlea or after surgical closure of the opening to implant the cochlea. In some scenarios, cochlear implant recipients can experience changes, such as during the years or decades after implantation in which the device is still implanted, and such people can be subject to ongoing disease processes in their implanted ear, as well as normal human processes such as puberty, menopause or ageing. Embodiments include accounting for changes that can occur less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55 or 60 years or any value or range of values therebetween in 1 month increments after implantation, and any disclosure herein of a method action or portion thereof constitutes doing such in any one or more of the aforementioned timeframes, providing that the art enables such, for the purposes of textual economy (instead of textually repeating such actions), as well as using any device and / or system disclosed herein for such, or vis-a-versa. In some scenarios, some of these will be transient and frequent or infrequent, while otherswill be more permanent. Some phenomena can be insignificant and some can be clinically significant. Some can effectively interfere with operation of the cochlear implant or otherwise require an effective change in stimulation strategy or output of the cochlear implant. Embodiments can include a system that records the history of impedances and / or other measures and can apply algorithms to help differentiate between the multiple possible states of these variables, which in turn are used to provide insight and guidance into a need or lack of need for clinical intervention.

[0076] Embodiments include scenarios where impedances can rise significantly due to periods of non-use. Embodiments include scenarios where impedances are higher in the morning where recipients have not used their implant overnight, for example. Scenarios include situations where impedances for electrodes that are de-activated are high relative to activated electrodes. Scenarios which are accounted for herein can include accounting for people who tend to not use their cochlear implant device(s) and thus see levels or impedance changes reflecting their usage patterns (or lack of usage patterns). For example, some bilateral recipients use one device substantially more than the other and thus the impedance values can be different between the two devices, all other things being equal.

[0077] Scenarios include accounting for progression of some diseases can impact impedances over the long term, such as, for example, otosclerosis and / or or meningitis, and / or accounting for aetiologies and / or chronic diseases that tend to result in fluctuating impedance and / or drug regimes and / or diet that can affect impedances and / or the presence of air bubbles over a plate electrode that can resulting in temporary high impedances, and / or the occurrence of characteristic degradation and / or or open circuits or short circuits vis-a-vis impedance reading evaluation.

[0078] To be clear, embodiments include evaluating data based on impedance values obtained at time X (e.g., within minutes or hours or days or a week for example of the actual underlying impedance value readings being taken) while taking into account one or of the above possible scenarios so as to evaluate the data based one impedance values in a more realistic or otherwise more meaningful manner relative to that which is otherwise the case or otherwise evaluating such readings within a vacuum.

[0079] Various scenarios are presented herein. Any disclosure herein of a method action or portion thereof constitutes doing such in any one or more of the scenarios herein, providingthat the art enables such, for the purposes of textual economy, as well as using any device and / or system disclosed herein for such, or vis-a-versa.

[0080] Embodiments include clinicians executing one or more of the teachings herein by way of “seeing” recipients for a check-up on some regularly (e.g., every 12 months or 6 months, etc.) where during such visitation, impedances are taken during the session, such as the beginning of the session as a check on the status of the cochlear implant. Heretofore, because these checks are sometimes relatively infrequent (which may be the case in some embodiments herein), the clinician may or may not have seen a transient impedance change. If regular checkups are scheduled and executed upon, for example, a clinician may see different results which may be confusing and / or misleading without the teachings herein. Without the teachings herein, such could result in a clinician missing a significant change in state for the recipient and / or misinterpreting the measurement which could in turn result in a delayed treatment or incorrect / unnecessary diagnostic measurements or treatment and waste of time and resources. Embodiments include implementing the teachings herein to reduce the likelihood of such and / or avoid such, all other things being equal. Such reductions from a baseline without one or more of the teachings herein can be a reduction by 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90 or 95% or more or any value or range of values therebetween in 1% increments (e.g., 44, 66, 33-55%, etc.).

[0081] Embodiments include monitoring and storing records of impedances and other measures such as by way of example, electrocochleography, on some regular basis between clinic visits, and comparing with historical results, so as to provide greater insights and improve decision-making when clinicians detect changes in impedances. By way of example, addition of more information such as aetiology, stimulation data logs (how the device was used at the micro-level (charge values, etc., more on this below), and / or electrode array insertion depth can be used in algorithms to determine whether an impedance measurement is an indicator of some clinically significant issue requiring or otherwise warranting investigation and treatment, or a temporary and insignificant event requiring no action. As described earlier, the measures of a particular recipient can be compared to a normative database and analyzed using machine learning or other artificial intelligence techniques, all by way of example.

[0082] FIG. 11 shows another exemplary algorithm for an exemplary method, method 1100. Method 1100 includes method action 1110, which includes the action of obtaining first data, the first data being based on impedance measurements from inside a human during a firsttemporal period. In an embodiment, these impedance measurements are obtained with a cochlear implant electrode array located in a cochlea of a human, wherein the impedance values are values for impedances existing within the cochlea within X hours of the electrode array first entering the cochlea (or within X hours from final placement of the cochlea or within X hours from the end of the closure procedure, or within X hours from the time that the recipient leaves the operating room), wherein X can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 or more, or any value or range of values therebetween in 0.1 increments.

[0083] In an exemplary embodiment, the action of obtaining data based on impedance measurements can include actually operating the cochlear implant electrode array in accordance with the teachings herein. In an exemplary embodiment, the action of obtaining data based on impedance measurements within a cochlea of a human can include receiving the values from a third party, such as from a hospital that is remote from a data center or remote from a clinician or inner ear specialist who is reviewing the data (and thus executing the method). Thus, data based on impedance values can be the impedance values or can be a data set that is compiled based on impedance values or data that is compiled based on data that is compiled based on impedance values.

[0084] In an exemplary embodiment, the data can include impedance measurements for all or some of the read electrodes at a first temporal period (and the second temporal period for the second data detailed below, and they need not be for the exact same electrodes). In an exemplary embodiment, the obtained data can be data that is statistically manipulated or otherwise conditioned. Mean, median and / or mode of measurements can be included in the data, for some or all of the electrodes. In an embodiment, the obtained data can be the raw impedances for one or more of the electrodes or a combination thereof. The obtained data can be obtained at the time that the impedance measurements are taken, or at a later time. That is, method action 1110 can occur minutes or hours or days after the first temporal period.

[0085] Method 1100 includes method action 1120, which includes obtaining second data based on second impedance values obtained with the cochlear implant electrode array still located in the cochlea of the human, wherein the second impedance values are for impedances existing within the cochlea after at least Y hours of the electrode array first entering the cochlea (or any of the other temporal markers noted above), wherein Y can be 2,2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 50, 55, 60, 65, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500, 550, 600 or more, or any value or range of values therebetween in 0.1 increments.

[0086] It is noted that the impedance measurements for all of the read electrodes need not necessarily be present in the data obtained, whether for the data of method action 1110 or 1120. Indeed, in an exemplary embodiment, a data set for the first temporal period, which could be a location or a plurality of locations, may or may not have one or more impedance values for one or more read electrodes whereas the data set for the second temporal period may have one or more those impedance values for the read electrodes. That is, the data sets need not necessarily be exhaustive or otherwise identical providing that the data obtained can enable the teachings detailed herein.

[0087] Method 1100 further includes method action 1130, which includes clinically interpreting the second data based at least in part on the first data as a historical baseline. This is not simply comparing impedance values associated with a first temporal location to a second temporal location for example. Here, the first data is utilized as a baseline, or otherwise a set of data from which all other data will be compared in this exemplary embodiment. The impedance may change as noted above, for one or a plurality of reasons. The question is whether or not the change is indicative of a change that has clinical significance as opposed to one that does not, and there, the concept of a baseline comes into play. Note further that mere size of change may not be indicative of clinical significance. In fact, it could be that if there is no change, that in and of itself indicates clinical significance.

[0088] Embodiments include determining a temporal difference between the first temporal period and the second temporal period and clinically interpreting the second data based on the determined difference. In this regard, it can be understood that embodiments of executing method action 1130 are not based solely on comparing impedance values and measurements to one another with respect to the action of clinically interpreting the second data. Here, the length of time that has elapsed from the first temporal period to the second temporal period is utilized in the clinical interpretation or otherwise when evaluating the second data. In this regard, by way of example only, it should be expected that impedance values or measurements will increase over time after the cochlear implant electrode array is inserted into the cochlea. Thus, consistent with the teachings above, embodiments include taking intoaccount the fact that the impedance will change based on a number of factors as the tissue undergoes a normal healing process. In an embodiment, the temporal difference between the first temporal period in the second temporal period can be when the foreign body reaction occurs. Embodiments thus include discounting for the rise in impedance resulting from such based on the temporal difference. And briefly, it is noted that in an exemplary embodiment, there is a method of determining the time from an implantation surgery, which could be the time from any of the given actions herein, whether such as surgical closure or whether such is first entry of the electrode array into the cochlea, or whether such is first entry of the surgical tool, such as a surgical drill, into the cochlea, or the commencement of drilling or otherwise accessing the cochlea for that matter.

[0089] Embodiments include evaluating the difference between the first data and the second data, or more specifically, the difference in impedance measurements that are relevant of the first data and the second data in conjunction with the time period that has elapsed between when the impedance measurements upon which the first data is based or taken and when the impedance measurements upon which the second data is based. In an exemplary embodiment, if the impedance value between electrodes 2 and 3 of the second data is within a percentage range higher than that of the first data, after Z number of hours from the electrode array first entering the cochlea, it can be determined that the impedance increase is within normal limits for that temporal qualifier. Conversely, if the impedance value for the second data is higher than that percentage range or lower for that matter than that percentage range (if there is no impedance rise when one would expect, that could be indicative of another ailments or physiological problem with the person, or, at a minimum, a device defect or otherwise device malfunction or otherwise data corruption) at that temporal qualifier, that can be an indication that some action should be taken or at least some additional attention should be given to the patient, or otherwise an additional data set for the second data should be taken as a precaution. Embodiments will also include an algorithm at least for other temporal qualifiers shorter than Z and / or longer than Z. There could be ranges for five or 10 or 15 or 20 or 30 or 40 or 50 or more temporal qualifiers or any value or range of values therebetween in one qualifier increment. And note that embodiments can be implemented where the cochlear implant performs the impedance collection actions automatically, and data based on the measurements is automatically transmitted to the external component or another device that enables the ultimate acquisition of the data by a clinician or a healthcare professional or by an automated system that can automatically evaluate the data, all consistent with theteachings detailed herein. Indeed, with respect to implementations within close temporal proximity of the original insertion of the cochlear implant electrode array into the human, it could be that the action of taking the impedance measurements is under the control of a healthcare professional owing to the more sensitive nature thereof as opposed to times further distant from the initial insertion.

[0090] In any event, in an exemplary embodiment, if the impedance rise at a given temporal marker, such as after a certain amount of time after the initial implantation surgery or what have you, is outside a certain range or otherwise above a certain limit, such could be indicative of an excessive foreign body response, which body response could result in damage to any residual hearing or otherwise the creation of tissue about the electrode array in amounts that could detract from the utilitarian use of the cochlear implant electrode array, such as requiring higher current levels, and thus reduced battery life. In an embodiment, action could be taken to limit the foreign body response, such as by way of example, via the application of drugs. Conversely, those drugs could have a deleterious effect with respect to interfering with the normal foreign body response, hence why it might be utilitarian to withhold the delivery of the drugs if the difference in impedance measurements is within a given range or below a certain threshold at the temporal marker at issue. Yet there is the dichotomy that if there is no indication of an increase in impedance, or otherwise increase in impedance is below a minimum value that would otherwise be expected for the given temporal marker, the drug or otherwise therapeutic substance could be provided in an abundance of caution. In an exemplary scenario, because the data is indicative of false data or otherwise that proper impedance measurements are not being executed, a determination can be made that the healthcare professionals are effectively “blind” with respect to what exactly is going on in the cochlea or otherwise the pertinent foreign body response, and thus in an abundance of caution, the drugs are given, even though there could be deleterious effects associated therewith. Put another way, if there is not enough information to make a decision one way or another, that simple fact can allow the healthcare professional to err on the side of caution.

[0091] Embodiments include implementing treatments based on the analysis detailed herein, including the clinical interpretation, of the impedance measurements.

[0092] In an embodiment, the first and second impedance values obtained with the cochlear implant electrode array were obtained using four-point impedance techniques. In an embodiment, the first impedance values are impedance values that existed within 6, 5, 4, 3, 2,or 1 hours of the electrode array first entering the cochlea, concomitant with the teachings above, and the second impedance values are impedance values that existed more than 18 hours and less than 30 hours from the electrode array first entering the cochlea, again concomitant with the teachings above.

[0093] In an embodiment, the first and second impedance values obtained with the cochlear implant electrode array were primarily influenced by the environment surrounding and / or adjacent the electrodes used to measure the first and second impedance values, or otherwise the environment within the cochlea.

[0094] In an embodiment, the implemented treatment is a treatment for treating an ailment, the symptoms of which are not present at the time of implementing and the treatment the aggressiveness of which is increased is a treatment for treating an ailment the symptoms of which are not present at the time of increasing. In some embodiments, method 1300 further includes the action of normalizing the first data to account for variations in the impedance measurement that are statistically likely to dissipate with time.

[0095] As noted above, not all impedance values, or more accurately, not all read electrodes or the data therefrom need be used. In an embodiment, the first impedance values are impedance values for Z of the first 3, 4, 5, 6, 7, 8, 9, or 10, or any value or range of values therebetween in 1 increment read electrodes of the electrode array, the first of the number of electrodes being the most basal electrode, where Z can be 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, or any value or range of values therebetween, and can start 1, 2, 3, 4, or 5 read electrodes from the first. Moreover, the second impedance values are impedance values for any one or more or all of those electrodes (they need not be the same, and can have the same constraints just detailed). In some embodiments, the first impedance values are impedance values for Z of a first number of read electrodes of the electrode array, the first of the first number of electrodes being the most basal electrode, and the first number of read electrodes being located in the basal portion of the cochlea and the second impedance values are impedance values for Z of the first number of read electrodes or any one or more or all of the first number. And note that the second impedance values can include other read electrodes not used for the first (such as, for example, to make up for an extraneous datapoint or a failed electrode).

[0096] In some embodiments, values from one or more of the read electrodes can be discounted or otherwise disregarded, such as when, for example, the values appear to beextraneous or otherwise are anomalous. Indeed, as noted above, embodiments include normalizing or otherwise statistically adjusting the first data. The second data can also be normalized or otherwise statistically adjusted.

[0097] In some embodiments, any one or more of the following read electrodes, starting from the most basal read electrode (as oppose to the most basal electrode, which cannot be a read electrode), can be used to obtain the first and / or second impedances (and they need not be the same but can be the same): read electrode 1, 2, 3, 4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, and / or 30 (the industry currently uses a maximum of 22 intra-cochlear electrodes total on most cochlear implant electrode arrays, but embodiments can use more extensive numbers of electrodes on arrays).

[0098] In an embodiment, the first impedance values are impedance values for all or a subset of a first number of read electrodes of the electrode array, the first of the first number of electrodes being the most basal electrode, and the first number of read electrodes subtending at least an angle of 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320 or 330 degrees or any value or range of values therebetween in 1 degree increments within the cochlea, and in some embodiments, not exceeding 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, or 360 degrees, or any value or range of values therebetween in 1 degree increments within the cochlea. In an embodiment, the second impedance values are impedance values for all or the subset or another subset of the first number of read electrodes.

[0099] In an embodiment, the most basal first, second, third, fourth, fifth, sixth, and / or seventh read electrode (e.g., read electrodes 1, 2, 3; 1, 2 and 5; or 1 and 6) are excluded from the electrodes used for the first and / or second values.[ooioo] As referenced above, embodiments include a method action of determining an insertion depth of the electrode array. In this regard, this can be achieved by accessing data from the surgery, such as the records of the surgeon(s) and / or utilizing automated or semiautomated techniques, such as, for example, onboard sensing systems that enable the cochlear implant electrode array to develop data that can provide an indication as to how many electrodes are located inside the cochlea and / or how many electrodes are not located inside the cochlea, which can be utilized to determine the depth of insertion in some embodiments if the geometry of the electrode array is known, such as the location of the given electrodes along the length of the array. By way of example only and not by way oflimitation, it can be that not all of the electrodes along the electrode array, as distinguished from, for example, the return electrode or electrodes that are specifically designed to be extra cochlear electrodes, or located in the cochlea at the completion of surgery or otherwise after the electrode array is “finally” seated within the cochlea based on the determination of the surgeons or otherwise their desired placement thereof. Alternatively, it could be that there is a migration of the electrode array after the final placement, including after closure of the surgical access point. In any event, for whatever reason or whatever scenario that has caused such, it could be that not all electrodes of the electrode array are located within the cochlea. Conversely, it could be that all of the electrodes are so located therein, but that fact is not necessarily known, or otherwise there is utilitarian value in reaffirming such or otherwise checking that such is the case, so as to avoid overconfidence or otherwise general assumptions. Thus, however it is done, embodiments include determining an insertion depth of the electrode array, by whatever metric is utilized, whether that be electrode number and / or distance, etc.[ooioi] In an embodiment, such as where the medical device is a cochlear implant electrode array, there is an increase (any of those detailed herein by way of example in the interests of textual economy) in impedance between a first temporal period and a second temporal period (any of those detailed herein by way of example in the interests of textual economy) and the method further comprises determining an insertion depth of the electrode array and the action of clinically interpreting the second data includes clinically interpreting the second data based at least in part on the insertion depth of the electrode array. In an embodiment, such as where the medical device is a cochlear implant electrode array, there is a decrease (any of those detailed herein by way of example in the interests of textual economy) in impedance between the first temporal period and the second temporal period and the method further comprises determining an insertion depth of the electrode array and the action of clinically interpreting the second data includes clinically interpreting the second data based at least in part on the insertion depth of the electrode array.

[0102] In an exemplary embodiment, the action of clinically interpreting the second data includes clinically interpreting the second data based at least in part on the insertion depth of the electrode array. In this regard, by way of example only and not by way of limitation, in at least some scenarios, the largest increase in impedance measurements between the first data and the second data could occur at the most basil electrodes or otherwise the electrodes are closest to the bone wall between the cochlea and the middle ear in the case of acochleostomy, or otherwise the barrier between the cochlea in the middle ear in the case of a round window insertion for example. This is where there is utilitarian value with respect to knowing the insertion depth of the electrode array. Here, if the electrode array is not inserted all the way or otherwise there are electrodes that are not all the way inside the cochlea or otherwise not exposed to perilymph, or otherwise directly proximate the bony tissue of the wall between the cochlea in the middle ear, the impedance values could be relatively high for those electrodes. Granted, this data could flush itself out with respect to the comparison between the first data and the second data in a scenario where the electrode array has not moved, but again, embodiments also take into account the scenario where the electrode array has moved since the underlying measurements for the first data were executed. Even then, the impedance changes could still be large or small for that matter for electrodes that were always in the cochlea, depending on their placement within the cochlea. Accordingly, knowing the proximity of a given electrode, or more accurately, the proximity of the read electrode upon which the impedance measurements correspond to the most basal portion of the cochlea, in absolute terms are relative terms or whatever terms can have utilitarian value, can be utilized in the action of clinically interpreting the second data. Such can account for the scenario detailed above where the impedance of the basil electrode contacts rise over the weeks following surgery with tissue growth around the electrode array at the opening of the cochlea at a rate higher than that of some other electrode contact by way of example. That is, in an exemplary embodiment, it is expected that, say, the most basil one or two or three or four or five electrode contacts will experience impedance measurement changes that are effectively or otherwise significantly different than some other electrode contacts of the electrode array. Knowing this can be utilized to interpret the rise in impedance following surgery. Note also that knowing whether or not an electrode contact is outside the cochlea or otherwise in the middle ear can also have utilitarian value with respect to interpreting the rise in impedance post surgery, if such exists. Conversely, if there is no rise in impedance, such as might be the case with respect to a contact that is not located in the cochlea, knowing that that contact is not in the cochlea can have utilitarian value with respect to recognizing that the lack of increase in impedance is not a problem with the diagnostics or otherwise with the healing process for example, and thus can be discounted. Indeed, in an exemplary embodiment, electrode 1 out of a 22 electrode array should be the most basil electrode for a fully inserted electrode array, and thus in theory, should see the highest increase in impedance thereat following surgery. This thus can have utilitarian value with respect to providing a baseline in the second data for evaluating impedance values at other contacts inthe second data. However, if it is not known whether or not electrode 1 or electrode 2 or whatever electrode is located in the cochlea, that data could be effectively useless with respect to implementing the teachings detailed herein. In any event, impedance rise should exist for electrode contacts closer to the basal -most portion of the cochlea post surgery, and knowledge of the location of the electrodes within the cochlea, more accurately, how far those electrodes are inserted, if at all, can have utilitarian value with respect to clinically interpreting the second data.

[0103] In an embodiment, the impedance measurements of the second data are impedance measurements after an effectively significant period of non-use of a stimulating medical device implanted in the human; and the action of clinically interpreting the second data includes taking into account the effective significant period of non-use. This thus can address the scenario where the recipient utilizes only one of two cochlear implants during a given temporal period, or does not utilize his or her single cochlear implant (or both for that matter) overnight while sleeping, or otherwise chooses to have “off coil time” for whatever reason (some cochlear implant recipients who have not experienced hearing before receiving the cochlear implant find background noise irritating if not outright disturbing, and thus could choose to go for periods during the day, such as while working, with the cochlear implant turned off or otherwise without the external component in signal communication with the implantable component, thereby preventing the electrodes of the implant from providing current to the cochlea, or at least effective amounts of current that could result in a change of impedance for one or more electrodes). In such exemplary scenarios, it could be that impedance readings are higher relative to that which would otherwise be the case if the cochlear implant had been used in the preceding 1 or 5 or 10 or 15 minutes or 30 minutes or one hour or two hours or any value or range of values therebetween in one minute increments before the second data, more accurately, the impedance measurements were taken for the second data. Embodiments include taking this into account when clinically interpreting the second data. Accordingly, in an exemplary embodiment, if one or impedance measurements are higher than that of a corresponding first measurement, that could be indicative of a problem whereas the variable might not be indicative of a problem, with respect to the latter scenario, that could be because the cochlear implant had not been used for hours for example prior to the action of obtaining the measurements for the second data. Accordingly, in an embodiment, different ranges could be applied in the action of interpreting the second data based on whether or not the implant had been used in the temporal period immediately beforethe measurements were taken. For example, if there is a general baseline / historical data set after the recipient’s condition has stabilized or otherwise the physiological aspects within the cochlea have stabilized, which could be less than or greater than and / or equal to 1 or 2 or 3 weeks or a month or 2 or 3 or 4 or 5, 6, 7, 8, 9, 10, 11 or 12 months or any value or range of values therebetween in one week increments after the implantation of the electrode array into the cochlea, this historical baseline could be adjusted to account for the increased impedance according to this given scenario by, for example, a 30% value or 40% value or any value that can have utilitarian value, which can be obtained through empirical testing over a number of recipients or could be subjected to the individual recipient, or otherwise can be developed based on calculations. Thus, if the second data set has values that are relatively high, but it is determined that the above noted periods of nonuse exist, it could be that it is determined that those high values are acceptable or otherwise not indicative of a problem or something that warrants attention, or at least not immediate attention relative to that which would otherwise be the case.

[0104] Note that in an embodiment, it could be that because there was a period of nonuse, and the impedance values were higher than that which would be expected, notwithstanding the period of nonuse, the algorithm applied could indicate that additional impedance testing should be taken in an hour or after a certain period of time of use of the cochlea has transpired, such as, for example, at least 15 minutes or / i hour or 45 minutes or an hour, etc.

[0105] And note that the embodiment associated with nonuse is not necessarily linked to the period of time after surgery. Again, the first data could be data collected well after the period of surgery, more on this below. Again, the first data could be the baseline data after the implant has stabilized.

[0106] Accordingly, embodiments include taking into account impedance changes that reflect usage or non-usage of the cochlear implant or otherwise the patterns of usage or nonusage when evaluating impedance readings or otherwise data based on impedance readings, where the conclusions associated there about can be effectively clinically different relative to that which would otherwise be the case all other things being equal.

[0107] Embodiments include conditioning electrode so as to enable electrodes to be more easily used for impedance purposes in combination with the historical features detailed herein associated there with. In an embodiment, the utilization of electrical stimulation or otherwise the transfer of charge can be utilized to condition the electrodes so as to reduce theimpedance. Embodiments utilize history to extract diagnostic information, as noted above. In embodiments, the conditioning can reduce impedance by less than, greater than and / or equal to, 5 or 10 or 15 or 20 or 25 or 30% or more or any value or range of values therebetween in 1% increments. Embodiments can include utilizing the teachings detailed herein to reduce the impedance, which impedances utilized for diagnostic purposes, to his low value as possible or otherwise in a manner that has utilitarian value. Effectively as low as possible is what will be implemented in at least some exemplary embodiments. Note that impedance is a state and impedance measurements are indicative of that state. Thus, embodiments include taking actions before measuring the impedance, which actions reduce the impedance. Any action that can be taken to condition the electrodes and otherwise remove or clean proteins or otherwise to reduce the impedance that is present proximate the electrodes can be utilized in some embodiments, providing that such result in an efficacious results and otherwise enables the teachings herein. In an embodiment, so conditioned electrodes are used to practice NR.T, and thus embodiments include executing one or more actions of an NR.T regime.

[0108] Embodiments include measuring the change in impedance before and / or after conditioning. In an exemplary embodiment, the amount of change, or more accurately, the percentage change, is utilized to determine whether or not fiber or proteins are proximate (or were proximate) the electrodes.

[0109] Embodiments include utilizing the teachings detailed herein to obtain equilibrium. Embodiments include preventing the electrode at issue that is utilized for impedance measurements from being utilized for any of the temporal periods herein so as to achieve equilibrium, and then practice the diagnostic teachings herein.

[0110] Embodiments also include obtaining or otherwise determining a drug regime and / or a diet of the human and clinically interpreting the second data based on the drug regime and / or the diet. In this regard, by way of example, a diet that is high in salt or low in salt can affect impedance values. Corollary to this is that if the recipient is dehydrated that too can affect the impedance values. Also, drugs whether or not directly applied to the cochlea or otherwise drugs that can pass the blood labyrinth to reach the fluids of the cochlea can also change impedance values. Accordingly, there is utilitarian value with respect to adjusting acceptable values and / or unacceptable values of impedance (or more accurately, inaction and action values and ranges of impedance) based on this knowledge.[oom] In an embodiment, the impedance measurements of the first data are impedance measurements for a steady-state environment and the impedance measurements of the second data are impedance measurements after the steady-state environment has been disrupted. By way of example only and not by way of limitation, as noted above, air bubbles can result in temporary high impedance values, such as where an air bubble is approximate the return electrode or proximate one or more of the electrodes within the cochlea, although such is typically the case with respect to times proximate implantation. In this regard, in an exemplary embodiment, the time period between the acquisition of the measurements of the first data and the acquisition of the measurements of the second data can be less than, greater than and / or equal to 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 125, 150, 175 or 200 months or more or any value therebetween in one week increments. Accordingly, there are embodiments where, for example, a deviation from the baseline occurs or otherwise is identified, and the method further includes evaluating the recipient or otherwise the physiological conditions of the recipient to determine if there is a non-cochlea related cause related (including non-directly cochlea related, which would include diet or drugs for example, although such would the an indirectly cochlea related cause) for such deviation, such as a change in state of the implant or a condition inside the recipient’s body proximate a portion of the implant outside the cochlea for example. Of course, additionally, as noted above, the implant can experience degradation over time were open circuits or short- circuits, which also can result in the change from baseline conditions by an amount beyond that which would otherwise be expected or otherwise be considered a normal variation there from.

[0112] In an embodiment, the impedance measurements of the first data are impedance measurements for a pre-diseased cochlea and the impedance measurements of the second data are impedance measurements for a post and / or current diseased cochlea. That said, the diseases need not necessarily be limited to the cochlea, and thus in embodiments, the first data are impedance measurements for a pre-diseased ear system of the human and the second data are impedance measurements for a post and / or current diseased ear system of a human. In an exemplary embodiment, the elements could be otosclerosis and / or meningitis. Embodiments thus include testing for one or more ailments or otherwise obtaining data indicative of whether or not the recipient has one or more ailments before and / or after obtaining the second data and / or after evaluating the second data or otherwise clinicallyinterpreting the second data. An embodiment can include clinically interpreting the second data based on the determination of the disease or presence of the disease or absence of such. Corollary to this is that, as noted above, scenarios exist where people with aetiologies and / or chronic diseases can have fluctuating impedances. Accordingly, embodiments thus include testing for one or more of these aetiologies and / or chronic diseases or otherwise obtaining data indicative of the presence and / or absence of such, and clinically interpreting the second data based on a determination of the presence or absence of such. Still, corollary to this is that in scenarios where impedance values were aberrant, such could be an indicator to test for or otherwise determine if the human is afflicted with such ailments.

[0113] Still with reference to method 1100, in an exemplary embodiment, the method further comprises at least one of determining a life-state of the recipient (e.g., a normal human process such as puberty, menopause and / or aging), determining a temporal proximity to a statistically significant period of non-use relative to the impedance measurements during the second temporal period (for example, if the second temporal period started and / or otherwise was encompassed within five or 10 minutes of a 12 hour period of nonuse, as opposed to the second temporal period started and / or otherwise was encompassed within three hours of a five minute period of nonuse) or determining a status of an ongoing disease process in the recipient and / or determining a sleep cycle of the human relative to the second temporal period. In an exemplary embodiment, the method includes clinically interpreting the second data based on one or more of these determinations. With respect to the concept of statistical significance, this can be based on empirical data for a sufficient number of examples in general and / or specific to a certain demographic that has the correlation with the recipient or statistically significant scenarios that are subjective to the specific person. In any event, in some embodiments, when the clinical interpretation of the second data is at least based in part on any one of these, the ramifications of the impedance ratings can be evaluated in a greater context or otherwise other factors that could result in changes in impedance can be taken into account. Thus, the evaluation of the second data relative to the first data can be executed outside of the vacuum of information.

[0114] Figure 12 presents an exemplary algorithm for an exemplary method, method 1200, which includes method action 1210, which includes obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period. This first data can be the first data or the second data detailed above with respect to method 1100 by way of example. Moreover, the first data of method action 1210 can be thecombination of the first data and the second data of method 1100 detailed above, such as, where, for example, the first data is the impedance increase values for one or read electrodes on the electrode array. (It is briefly noted that while the embodiment of method 1100 was presented in terms of clinically interpreting the second data based on the first data, in an alternate embodiment, there is no first data or otherwise the first data is not utilized in the clinical interpretation, and the clinical interpretation can be based on only the second data and the above examples of what the interpretation can be based upon, by way of example only and not by way of limitation.) Additional details of this are made by reference to other teachings detailed herein in the interest of textual economy. Method 1200 further includes method action 1220, which includes the action of obtaining second data, the second data being data based on one or more state conditions precedent the first temporal period, and method action 1230, which includes the action of clinically interpreting the first data based at least in part on the second data.

[0115] With respect to method action 1220, in an exemplary embodiment, such as where the human is a recipient of the cochlear implant electrode array, the state conditioned media type of entry through which the electrode array was extended into the cochlea. In this regard, the type of entry could be by way of cochleostomy or round window insertion. In this regard, if impedances of basal electrode contacts rise over the days and / or weeks following surgery with tissue growth around the electrode array at the opening of the cochlea, the impedance rise can be discounted or not discounted based on factors such as the type of entry into the cochlea. For example, a cochleostomy can generate bone growth which many give rise to higher levels of impedance values in the period after cochlear implantation compared to a round window insertion, which can give rise to fibrous tissue growth, which can result in a lower impedance rise relative to that which results from bone growth, all other things being equal. Thus, by way of example only and not by way of limitation, if the first data indicates an increase in impedance by a certain percentage over a given temporal period, the acceptable increase or otherwise the increase that would not warrant action could be higher for an array inserted via cochleostomy than through a round window and vice versa. Accordingly, the action of clinically interpreting the first data could be based at least in part on the type of entry into the cochlea.

[0116] And consistent with the teachings above regarding the depth of insertion, in an exemplary embodiment, the state condition is a depth of insertion of one or more electrodes into a cavity of the human, where, for example, the cavity is a cochlea, and the electrodes ofthe electrodes of the electrode array. Moreover, state conditions could be the state of disease or the state of an ailment of the human, or could be a temporal period for that matter. State conditions could be the operational state or nonoperational state of a feature of the implant, or otherwise a degraded state of the implant. A state condition could be the use of drugs by the human, etc. and in a derivative of such, a state condition could be whether there is a drug delivering feature of a medical device that is used to acquire the impedance measurements from inside the human. By way of example only and not by way of limitation, there are drug delivering cochlear implants that deliver drugs to a location inside the cochlea and / or inside the middle ear or to other parts of the human. And note that embodiments are not limited to applying the teachings detailed herein with respect to only a cochlear implant; any medical device to which the teachings detailed herein can have utilitarian value can be utilized in some embodiments, such as, for example, retinal implants and / or pacemakers and / or muscle stimulation devices or auditory brain stimulation devices or vagal nerve stimulation devices, or vestibular stimulation devices, etc. still, in at least some exemplary embodiments, whether or not the cochlear implant electrode array is, for example a dexamethasone eluting or otherwise delivering electrode array can be taken into account when clinically interpreting the first data. As noted above, such electrode arrays can suppress impedance rises or otherwise impedance values for months or years after implantation by way of example. Thus, embodiments can include taking into account whether or not there is ongoing drug delivery into the cochlea when clinically assessing the impedance data.

[0117] And referring back to embodiments where the use or nonuse of a cochlear implant can change impedance values with respect to the macroscopic use of the cochlear implant, in some embodiments, the state conditions can relate to microscopic use of portions of the cochlear implant. By way of example only and not by way of limitation, it could be that one or electrodes of the electrode array or otherwise the channels thereof are deactivated or otherwise not activated or otherwise not used during stimulation. This is distinguished from, for example, and on or off state of the cochlear implant or otherwise whether or not the cochlear implant in totality is being utilized. Here, the cochlear implant could be utilized on a regular basis, and one or more electrodes will never be used (unless activated). That is, if the cochlear implant was utilized 10 times over 10 days for 10 hours a day, to evoke a hearing percept over a host of ranges of frequencies, one or more channels of the cochlear implant will not be utilized to provide stimulation, and thus one or more electrodes will not be utilized to supply electrical current to the cochlea. This is not to say that there is an opencircuit for example. That is a fault within the device. Here, the device is intentionally programmed or otherwise intentionally set to not utilize one or more of those channels. In theory, this could be reversed or otherwise changed by uploading new settings or otherwise new stimulation strategies or control algorithms to the cochlear implant. Regardless, the point is that in an exemplary embodiment, the state condition of method 1200 is an activation state of an electrode (or 2 or 3 or 4 or 5 or 6 or 7 or 8 electrodes or any value or range of values therebetween in one electrode increments) of the cochlear implant electrode array or other medical device. Note this is also not whether or not an electrode is inserted into the cochlea. That is different. This is whether or not a channel or an electrode is activated. As will be described in greater detail below, and with reference to the above, the lack output current from an electrode for a certain amount of time will result in higher impedance values at that electrode or otherwise around that electrode relative to that which would otherwise be the case, all other things being equal. Accordingly, embodiments include taking into account whether or not an electrode has been deactivated for stimulation purposes when evaluating the first data. And note that the activation does not mean that that electrode cannot be utilized to determine impedance values there about. Just the opposite. The activation simply means whether or not that channel is utilized to stimulate tissue. And corollary at all of this is determining a deactivation state of an electrode within the human.

[0118] Embodiments also include evaluating a single set of impedance measurements obtained during a limited temporal period of time, such as within a minute or within an hour, during which it is unlikely that impedance values will change (that does not mean that the temporal limitations correspond to impedances that do not change -this is just simply an example of a short time period in which impedances may not change by a large percentage), and comparisons between the impedance values at one read electrode can be made relative to another electrode. A statistically significant difference between impedance readings at different electrodes can be indicative of fibrous tissue growth at some locations along the electrode array relative to others, or could be indicative of inflammation at some location versus others, or corrosion or some form of protein buildup on some read electrodes versus other electrodes, etc. all by way of example. Knowing whether or not a given electrode is in activated and / or deactivated electrode relative to another electrode of the electrode array can provide an indication as to whether or not the difference in impedance is a false positive of something that is going on, or the reverse, where a statistically insignificant difference in impedance where there should be one, such as for example where one or more of the readelectrodes is a deactivated electrode, is indicative of some form of problem. Embodiments thus include such determinations for such utility.

[0119] Any other state condition that can have utilitarian value with respect to clinically interpreting the first data can be utilized in at least some exemplary embodiments, providing that the art enables such, unless otherwise noted.

[0120] In an embodiment of method 1200, the first data includes impedance measurements monitored over at least and / or equal to and / or less than 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 days or any value or range of values therebetween in 1 hour increments in the human. In this embodiment, the state of method action 1220 is a partially healed cochlea in which a cochlear implant electrode array is located, which cochlear implant electrode array caused the need for healing (e.g., at least indirectly via the trauma of the implantation process, although there could be direct trauma from a foreign body response as well). In an embodiment, the action of clinically interpreting the first data includes determining whether or not the electroneural interface is trending to one of: (1) a normal and / or optimal state or (2) abnormal and / or suboptimal state based, based on a temporal location of a healing process resulting in the partially healed cochlea. (Note that such impedance measurements can have utilitarian value vis-a-vis assessing / estimating the effectiveness of a drug introduced into the body of the human that has the implant. In an embodiment, it can be that the electroneutral interface is "better than normal" when considering "normal" being without the drug. Thus embodiments can take into account whether this drug is being delivered or not being delivered to the human, to “adjust” or otherwise “discount” readings accordingly.) In this regard, if the state of the cochlea as being a partially healed cochlea is recognized, and otherwise taken into account when clinically interpreting the first data of method 1200, the impedance readings will make far more sense and otherwise will be far more meaningful and otherwise result in a more proper diagnosis relative to that which is otherwise the case. Here, if the time since the implantation process is known, and the measurements are correlated to such, all actions corresponding to at least some embodiments, the data can be evaluated to determine whether or not the trend is a good trend or a trend indicating a deleterious situation. Conversely, if it is known that cochlea is not a partially healed cochlea with respect to the electrode array causing the need for healing, such as where, for example, the first data is taken over a period of time that covers at least a year or more after the implantation of the array, or otherwise it is clinically understood that the cochlea has healed with respect to the implantation process, or otherwise based on a statistical analysis, the healing should becompleted, data that indicates relatively high impedances or impedances that are changing, such as, from relatively lower impedances to a relatively higher impedances, over the period of time of the first data, would be clinically interpreted as indicative of some form of problem with the recipient or device or a combination of both, or at least would be more viably interpreted as such. With respect to a scenario where the healing is due to the implantation, no action might be taken or otherwise less concern or less attention would be paid to the impedance changes or trend. Conversely, if the healing should have been done, and there are the above-noted impedance scenarios, it is more prudent or otherwise utilitarian to take some form of action or otherwise at least pay closer attention to the physiological conditions of the human or the conditions of the implant (e.g., heighten monitoring, heighten testing, take blood samples, etc.). That is, the teachings detailed herein can be utilized to better manage false positives and false negatives relative to that which would otherwise be the case in the absence of the teachings detailed herein.

[0121] It is noted that in an exemplary embodiment, the data based on the impedance measurements of method action 1110 can be data obtained in conjunction with stimulation history as will be described below. This can also be the case with respect to the data of method action 1120.

[0122] In view of the above, in an exemplary embodiment, there is a method according to the method actions of method 1200, where the impedance measurements are based on measurements made with a cochlear implant having electrode array located in the cochlea of the human. In an exemplary embodiment, the one or more state conditions include one or more of any of the state conditions detailed herein. In an exemplary embodiment, the one or more state conditions include one or more of an insertion depth of the electrode array in a cochlea, whether a portion of the cochlear implant extends through a cochleostomy or round window, whether the electrode array is located in a cochlea having a statistically large vestibular aqueduct and / or proximate a middle ear suffering from otosclerosis, whether a temporal period from implantation of a cochlear implant electrode array in a cochlea is within a statistically expected temporal period of healing or outside of the statistically expected temporal period of healing or whether the cochlear implant electrode array delivers therapeutic substance to the cochlea. With respect to the statistical expected temporal period of healing, this can be based on so-called “big data” for general cochlear implant recipients, or big data for cochlear implant recipients according to a given demographic and / or a type ofcochlear implants or a type of insertion of the cochlear implant or other factors that have a correlation with the particular human associated with the method.

[0123] FIG. 13 presents an exemplary method according to an exemplary embodiment, that includes method action 1310, which include obtaining first data, the first data including impedance measurements from inside the human during a first temporal period. This can be in accordance with any of the acquisition actions detailed above with respect to impedance measurements are data based on impedance measurements, etc., and note that the first data can include two subsets of data, such as the data of the first data and the data of the second data with respect to method 1100 detailed above. Any data that can enable the teachings detailed herein with respect to impedance measurements can be utilized in at least some exemplary embodiments would expect to the first data of method action 1310.

[0124] Method 1300 further includes method action 1320, which includes the action of obtaining second data, the second data including impedance measurements from inside the human during a second temporal period following the first temporal period, and method action 1330, which includes evaluating the second data based at least in part on the first data. Here, the evaluation can be clinical interpretation in accordance with the teachings above, but need not necessarily be such. Any evaluation of the first data based at least in part on the second data needs method action 1330.

[0125] With respect to the second data including stimulation history of one or more electrodes of an implanted medical device, here, as noted above, knowledge about whether or not an electrode of the electrode array has been deactivated or activated has utilitarian value with respect to clinically interpreting impedance values. Also, as noted above, knowledge about whether or not there were periods of disuse or relatively limited use can also have utilitarian value with respect to the interpretations. But there are some more subtle concepts as well that are related to method action 1320, as will now be described by way of example.

[0126] As noted above, electrical impedance can be used as objective measures to assess the biological environment adjacent to the electrode array, such as, for example, to objectively assess how much trauma was induced from implantation, the positioning of the electrode within scala tympani, the fibrotic tissue sheath encapsulating the array, the efficacy of a drug to prevent the encapsulation etc. However, stimulation currents passed from the electrode pads into neural tissue to elicit action potentials in the SGNs during normal cochlear implant use as well as electrophysiological measures such as impedance measures themselves canchange the electrical impedance of the electrode interface and / or biological environment desired to be assessed or otherwise intended to be assessed based on the first data of method 1300 (the data of method action 1310). This means the impedance measure can be different depending on the charge transfer history.

[0127] The implementation of the methods and systems herein can improve the correlation of impedance measures with the status / state of the biological environment to be assessed. This can provide a more meaningful objective measure for assessment of cochlear health in the clinical setting, by way of example. This can improve the confidence of the clinician and / or the patient through supported interpretation to explain impedance values and impedance changes. More specifically, when characterizing the physical properties of a system using a physical measure, this physical measure should not change the system to be characterized. If this cannot be avoided, the inflicted change needs to be known and the results adjusted accordingly to allow analysis. Herein, by way of example, this can include recording and / or reporting the charge transfer history, which can, in an embodiment, allow for the estimation / quantification and / or qualification of a change inflicted by the electrical stimulation, so as to adjust / calibrate (included in analyzing of method action 1330) the impedance data which is generated also using charge transfer to characterize the system’s status quo.

[0128] Briefly, the charge transfer history can include any one or more of the number of pulses, pulse width, and current levels and total charge passed of all intra- and extra cochlea electrodes. In an embodiment, this is continuously saved on memory onboard of the implant, or the external component, or a remote device such as by way of example only and not by way of limitation, a smart phone or smart device in signal communication with the medical device. When measurements for diagnostic and / or baseline reasons are taken, the charge transfer history of one or more or all of the electrodes, which is saved, can be attached to the impedance data to be used for analysis of the impedance data. For example, with respect to method 1300, first data and second data in a dataset.

[0129] Embodiments include utilizing the charge transfer history to validate or invalidate a measurement and / or calibrate / normalize the measured impedances. In an embodiment, a database of “diagnostic impedance” values is created to allow software / computer assisted interpretation of the impedances, although this interpretation can be done manually as well.

[0130] Embodiment can use data on frequency dependent resistance of a circuit for alternating current. Herein, any reference to impedance corresponds to a disclosure of suchin the interests of textual economy. Also, in the interests of textual economy, any reference to measuring impedance corresponds to a disclosure of any of the following:• Impedance measurement measured between any 2 intracochlear electrodes, any intracochlear electrode and any extra cochlear electrode, and any combination of electrode pairs. All impedance modes including conventional multipolar 1, multipolar 2, multipolar 1+2, bipolar, common ground, 4-point and any other possible combination of electrodes to form an electrode pair might be used to take measurements. To be clear, in some embodiments, there is a common ground (sometimes located outside the cochlea in the case of a cochlear implant for example) and 1 intra-cochlear electrode (ICE) against the 21 other ICEs as return path. In some embodiments, there can be 1 ICE with another ICE as current path, and 2 other ICEs can be used to measure the voltage drop. In an embodiment, there is the use of current between ICE 1 to 4, and measurement of voltage between ICE 2 and 3. This is meant to reduce the contribution of the complex Pt surface in a utilitarian value, and this can be done for ICE 2 to 5 (with measurement at 3 and 4), 3 to 6, etc. (Any of these four combinations can be used.)• Also included is the possibility to use one or two electrodes in addition to the electrode pair as reference electrodes as described in 4-point impedance measures.• Measurement using active and return electrode pairs and reference electrodes dedicated for impedance electrodes other than the standard intracochlear electrode and extra cochlear electrode electrodes of current cochlear implant electrode arrays.• For diagnostic purposes, a series of impedance measures may be taken either at the same or changing parameters (current level, pulse width, etc.) at defined time intervals and an equation is fitted to the impedance results. The param eter / constants of this fitted curve can be used for diagnostic purposes.• Measurements where impedance values measured include total impedance, and / or the resistive and / or capacitive components, and / or the phase angle between voltage and current. Standard biphasic square pulse signals as well as EIS typical sinusoidal signals can be utilized in some embodiments to conduct impedance measures.• Measurements where the impedance measures are triggered by an event, the recipient, a carer or health care professional and / or occur automatically at predefined time intervals, and / or when certain circumstances are given such as “coil on” but in a silent environment.

[0131] Embodiment include creating a diagnostic impedance database. By way of example, a “diagnostic impedance” database can be created based on existing and new clinical impedance data. This database can define “normal impedances” and “pathological impedances” (“impedances” include absolute impedances and impedance changes between one and a subsequent impedance measure) considering one or more or all of the following factors: a. “Charge transfer history” including total time of active cochlear implant (coil on), number of pulses, pulse width, and current levels and total charge passedthrough the electrode involved in the measurement by way of example one minute to 24 hours prior to the impedance measure. b. “Electrode entry” including round window, extended round window, cochleostomy. c. “Electrode position” including “insertion depth” of electrode in scala tympani, “modiolar distance” of electrode pad(s) used to measure impedance. d. “Electrode type” such as Cochlear Limited™ EA12, EA22, EA32, and the dexamethasone releasing variants (EA22D, EA32D) e. Implant duration (time from implantation to impedance measurement). f. “Patient data” including gender, age, aetiology, co-morbidity, other drugs such as anti -contraception, diabetes, etc. g. For diagnostic impedance testing, the correlation of an impedance change measured between a first impedance measure and a second impedance measure measured after one or a series of defined amount of charge has passed through the electrodes, such as by way of example and not by way of limitation InC to lOOOnC and / or charge density of IpC / cm2to 1000pC / cm2, again by way of example and not by way of limitation, using a set current level (amplitude of biphasic pulse), pulse width and / or pulse rate; h. The status of the electrode interface (e.g., cleanliness of the platinum pad surface, such as, for example, an amount of protein and cell adhesion) i. the biology adjacent to the electrode pads including the cellular composition (cell types), density, and thickness of the fibrous sheath, the perilymph composition including concentration and type of proteins and other organic constituents, the health of neural structures such as spiral ganglion cell population, the integrity of the blood-labyrinth-barrier, the cochlea seal around the electrode, the health of hair cells and other structures of the cochlea. j . The correlation of the charge required to cause an impedance change greater than lOOOhm to lOkOhm and the status of the electrode interface and biological environment (as described above).

[0132] In an embodiment, the “diagnostic impedance” database is saved on the implant, the external component or on a local computer or smart phone, or in the cloud or anywhere that can have utilitarian value. In an embodiment, the implant and / or the external component continuously records or records at utilitarian intervals the patient’s “charge transfer history” which can include for example a number of pulses, pulse width, and / or current levels and / or total charge passed through one or more or all of the intracochlear electrodes and / or extra cochlear electrodes.

[0133] In an embodiment, the patient’s continuously recorded “charge transfer history,” electrode array entry manner, the electrode array position, the electrode array type (straight or curved, etc.) and / or patient data is saved on the implant, external component or on a local computer or smart phone / smart device, or in the cloud, etc.

[0134] In an embodiment, when an impedance measurement is taken, software and / or a computer algorithm is used to compare the result to the appropriate impedance (which can be a range) in the diagnostic impedance database. In an embodiment, an automated system can be configured so that in a case the impedance falls within the “normal impedance” range, feedback is given to the clinician and / or patient that all is as expected. In an embodiment, an automated system can be configured so that in a case where the impedance falls outside the “normal impedance” range, feedback is given to the clinician that some abnormality is detected and further “diagnostic impedance” testing is required. In an embodiment, an automated system can be configured so that in a case where no valid impedance data exists in the “diagnostic impedance” database to compare it to, feedback is given to the clinician that further “diagnostic impedance” testing is required.

[0135] In view of the above, with respect to method 1300, in an embodiment, the stimulation history includes at least one of whether or when the one or more electrodes has been used for tissue stimulation. This as opposed to impedance for diagnostic testing. As used herein, tissue stimulation refers to stimulation applied by the medical device for an efficacious treatment or purpose, such as, for example, to control or adjust the beating of a heart or two evoke a sensory percept, such as a hearing percept or a visual percept, or to provide better balance with respect to a vestibular implant, or to control dizziness, etc. It could be that stimulation resulted from diagnostic tests. Indeed, in some embodiments, the diagnostic tests are performed while stimulating tissue utilizing the electrodes. Conversely, impedance values and measurements can be developed outside of a tissue stimulation action. Thus, in an exemplary embodiment, the stimulation history includes the last time with the length of time since or whether the one or more electrodes has been used to evoke a sensory percept or to control a physical phenomenon inside the human. Sometimes, current applied from the electrodes evokes a hearing percept while utilizing electrodes to measure impedance and sometimes it does not.

[0136] Consistent with the teachings above, knowing this history can provide a gauge or otherwise can aid in the evaluation of the obtained first data. Again, if stimulation of tissue utilizing the one or more electrodes occurred five minutes or three minutes prior to the impedance measurements obtained in the first data, it is likely that the impedance measurements will be lower relative to that which would otherwise be the case in the absence of stimulation for a longer period of time, or at least a substantially longer period of time. Certainly if the electrode had never been used to provide tissue stimulation, such as would bethe case for a deactivated electrode or otherwise electrode that is wired into a channel of a cochlear implant, e.g., that is not utilized as part of a stimulation strategy, the impedance values would be higher. Knowing this can enable a more conclusive / sound evaluation of the impedance measurements relative to that which would otherwise be the case.

[0137] In an embodiment of method 1300, the stimulation history includes data based on a feature relating to how much stimulation was applied by the one or more electrodes. This can be any factor related to such, such as current levels, the number of pulses, the pulse widths. The total charge can meet the data requirements. The number of electrons (rounded to a meaningful number or otherwise estimated number) passing through an electrode pad or the pads of the electrodes subject to the method can meet the data requirements. In an embodiment, the data is indicative of how much stimulation was applied. The history can be quantified or qualified data. Indeed, it may not be necessary or important to have exact figures. Data such as substantial stimulation or minimal stimulation or negligible or moderate stimulation can be embodied in the data. Any qualification or quantification that can enable the teachings herein can be used in some embodiments providing that the art enables such.

[0138] And note that the data based on the feature relating to how much stimulation is applied can be temporally based. For example, this could be over a period of time such as minutes or hours, and can be an average for that time (mean median and / or mode). The period of time could be specified or otherwise chosen as one that can have utilitarian value with the teachings detailed herein. For example, a period of time lasting two hours could be as utilitarian as a period of time lasting 10 hours. Conversely, the period of time lasting 10 hours could encompass substantial periods of nonuse which could skew the data. Any period of time that can have utilitarian value can be utilized in at least some embodiments. And of course this can be combined with the other features associated with the stimulation history detailed herein such as the amount of stimulation that was applied over a one hour temporal period within a two hour temporal period prior to the action of measuring the impedances of method 1310.

[0139] Figure 14 presents another exemplary method, method 1400, which includes method action 1410, which includes executing method 1300. In an exemplary embodiment, the medical device is a cochlear implant electrode array, and method 1400 further comprises method action 1420, which includes the action of method further comprises obtaining third data, which third data can be, by way of example, any of the state conditions detailed hereinor any of the other utilitarian data sets or information detailed herein that can have utilitarian value with respect to clinically interpreting the impedance data or otherwise evaluating the impedance data. In an exemplary embodiment, the third data can be based on insertion depth of the electrode array and / or whether the electrode array is inserted through a cochleostomy opening or another opening in the cochlea. In an embodiment, the action of evaluating the second data is based at least in part on the third data.

[0140] It is briefly noted that while the method actions detailed herein are presented with respect to identifiers such as “first” and “second,” it is noted that these are identifiers and do not provide temporal qualifications as to the method actions. By way of example only and not by way of limitation, the second data of method 1300 could be acquired before the first data of method 1300. And as will be understood with respect to method 1400, if method action 1330 is executed utilizing the third data, of course the method 1300 cannot be executed prior to the action of obtaining the third data. The method actions detailed herein can be practiced in any order providing that the art enables such, unless otherwise noted.

[0141] In an embodiment where for example the human is a recipient of a cochlear implant electrode array and the impedance measurements of data are impedance measurements for activated electrodes of the cochlear implant electrode array and impedance measurements for deactivated electrodes of the cochlear implant electrode array, and the stimulation history indicates that no stimulation has been provided for the deactivated electrodes (as would be the case for deactivated electrodes). A deactivated electrode does not mean that the electrode cannot be used or otherwise is not used to obtain the impedance data. Utilizing the electrode for stimulation purposes is different from utilizing the electrode for diagnostic purposes.

[0142] In an exemplary scenario of method 1300, the stimulation history indicates that the one or more electrodes have not been used in a substantial manner to stimulate tissue of the human within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35 or 40 hours or any value or range arise therebetween in one minute increments of when the impedance measurements from inside the human were obtained. In an exemplary subscenario of this scenario, the action of evaluating the first data includes determining that the impedance measurements indicate that the impedances fall within a first range that corresponds to statistical data indicative of normal impedance values even though the impedances measures are higher than a second range that corresponds to statistical data indicative of normal impedance values for a scenario where the stimulation history would otherwise indicate that the one or more electrodes have been used in a substantial manner tostimulate tissue of the human within less than 6, 5, 4, 3, 2, 1, 0.5, 0.25 hours or any value or range of values therebetween in 0.01 hour increments of when the impedance measurements from inside the human were obtained. In this regard, this is an exemplary embodiment where the lack of stimulation of tissue by the one or more electrodes for a given period of time results in higher impedance values relative to that which would otherwise be the case, and thus here, those higher impedance values are taken into account so that what otherwise would be a concerning set of measurements is deemed to be not concerning or otherwise deemed to be normal or otherwise acceptable because the high impedances are expected because the history of stimulation is known and is being taken into account. Still, it could be that the impedance values are so high that even after discounting or otherwise taking into account the fact that the impedance values were obtained after a meaningful and substantial period of nonuse or non-stimulation, the impedance values are still indicative of a problem, or the impedance values are lower than the range than that would be expected, which could indicate that additional testing can be utilized or that there is some form of problem, whether with the human or whether with the medical device.

[0143] Note also that the reverse can be true, such as where impedance values are obtained after a period of substantial stimulation and the impedance values are higher than the above noted second range, where the second range is for impedance values that would result after the expected substantial stimulation. Of course, if the impedance values are within the range that is deemed normal for a scenario where substantial stimulation has occurred in a temporally meaningful manner precedent the times when the measurements were taken for the first data, the values would be considered normal and no action would be taken.

[0144] Still further, in an exemplary embodiment, the stimulation history is based on data automatically obtained by a medical device in relation to the medical device providing stimulation to the human to evoke a macro neural response of the human (such as, for example, evoking a hearing percept revision percept or controlling or adjusting or pacing the beat of the human heart or stimulating the vagus nerve for efficacious inducement of neural plasticity, etc.) including data obtained continuously and / or sporadically over a one week period. This is in accordance with the exemplary embodiments detailed above, where the implant or the external component records or otherwise monitors various features associated with the charge transfer or otherwise the stimulation. This can be any of the values are features detailed herein, and others for that matter that can have utilitarian value unless otherwise noted. Note that it may not necessarily be required that the implant measuresfeatures associated with the charge transfer. It can be sufficient that the output or the control data is recorded or otherwise saved so that the charge can be “reversed engineered” or otherwise backed out of the data. That is, by way of example, the control signals that are applied to the implantable component from the external component, where the external component includes the control system, such as by way of example, with respect to a cochlear implant, the sound processor of the cochlear implant and the control components that convert the output of the sound processor to a control signal that can be transcutaneously delivered to the implant, can be recorded or otherwise stored or saved, and from this data, the charge transfer history can be extracted. And note that this information or data need not necessarily be obtained directly from the prostheses to execute this exemplary embodiment of method 1300. As long as the data is based on data from the prostheses, such can be utilized to meet this exemplary claim by way of example.

[0145] In an embodiment, there is a method 1500 according to the flowchart of FIG. 15, which includes method action 1510, which includes obtaining first data based on at least one variable of charge transfer data of electrodes implanted in a human. In an embodiment, the at least one variable of the charge transfer data includes at least one of total time of activation of a medical device, such as a cochlear implant, of which the electrodes are a part, a number of pulses of electrical current applied by the electrodes, pulse width of an electrical current applied by the electrodes, current levels applied by the electrodes or total charge passed through the electrodes. Thus, in an embodiment, the obtained at least one variable is a variable that originated from a hearing prosthesis and / or an accessory of the hearing prosthesis used by the human (with respect to the latter, a smart device in communication with the hearing prosthesis for example, that records the pertinent data - more on this below). In an embodiment, the at least one variable is based on data that was effectively continuously recorded over a statistically significant temporal period of use of the electrodes. In an embodiment, the at least one variable is based on data that was periodically and / or or variably recorded over a statistically significant temporal period of use of the electrodes. With regard to the former, there is utilitarian value with respect to obtaining as much data as possible, at least up to the point where the data ceases to be come useful or otherwise the data becomes unwieldy or otherwise cannot be stored in the memory devices of the components that are utilized to record such data, and in this regard, the utilization of a hearing prosthesis accessory device, such as a smart device in signal communication with the hearing prostheses, can enable the collection of substantial amounts of data owing to the memorysizes of such devices, which can exceed 25 or 50 or 100 or 200 or 300 or more gigabytes by way of example. Note that large memory devices and the external component can be utilized in some embodiments. Large memory devices can also be present in the implantable component although owing to size constraints, it is the case in at least some embodiments that the memory of the external device, if present, would be larger than the memory of the implantable device, again if present. In any event, any memory source that can enable data pertinent to the teachings detailed herein can be utilized in at least some exemplary embodiments, at least such is present on any one or the devices detailed herein or other devices that could be utilized with the components detailed herein.

[0146] With respect to the periodic and / or variable recording of data, it could be that sampling can be utilized as opposed to constant or continuous recordation of the data. In an exemplary embodiment, the at least one variable of charge transfer data could be recorded over a period of one second every five seconds or every 10 seconds or every minute for example, or over a period of a minute every hour or every half hour by way of example. Any recordation regime that can enable the teachings detailed herein can be utilized in at least some exemplary embodiments.

[0147] Note that embodiments can include periodically deleting data from the memories of the devices, such as the memory of the external component or the implantable component. This can be done as a matter of doctrine such as how a flight recorder operates on a commercial airplane or can be done every time the memory is stored in a remote device or on the cloud, etc. Still, embodiments include obtaining charge transfer data that was recorded effectively continuously (which includes continuously) or in a sampled manner, or any other utilitarian manner, over a temporal period within less than, greater than and / or equal to 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500, 1750 or 2000 minutes or 34, 35, 40, 45 50, 55, 60, 65, 70, 75 or 80 hours or more or any value or range of values therebetween in 0.01 minute increments prior to one or more impedance measurements, such as those detailed herein that are analyzed or otherwise interpreted in a clinical manner. In a relatively simple exemplary scenario, the charge transfer data is obtained for charge transfer that occurred within 24 hours prior to the impedance measurements that are to be analyzed, whether continuously or periodically or sporadically, providing that the acquisition is utilitarian. And note that it could be that the data that is obtained is pre-processed to an extent. For example, with reference to the abovequalifications and / or quantification, it could be that the data indicates that the number of pulses over an hour period exceeded a certain value or otherwise was deemed to be standard for standard use of a cochlear implant for example. Indeed, the data could be that the cochlear implant was utilized in a normal or average manner, based on statistics, and there can be predetermined values or data such utilization. In other words, it could be utilitarian to not have to store the exact data when the data can be easily qualified or quantified. Conversely, if the data is outside of a normal range or expected parameters or some other qualified or quantified predetermined data set, the data would be stored and / or maintained and time logged or catalogued in some manner, and the granularity of the data that is stored and maintained can be varied or can be stringently applied, such as all data that is recorded is stored. Accordingly, embodiments include “smart storage” techniques. That said, even if the data is aberrant or otherwise outside certain ranges, that too can be qualified or quantified. Any data that can enable the teachings detailed herein to provide utilitarian value can be utilized in at least some exemplary embodiments providing that the art enables such.

[0148] Still with reference to figure 15 and method 1500, method 1500 further includes method action 1520, which includes the action of obtaining second data based on at least one impedance measurement. The at least one impedance measurement can be obtained according to any of the teachings detailed herein, with reference made thereto, or any other regime that can enable the teachings detailed herein. Method 1500 further includes method action 1530, which includes the action of developing a correlation between the first data and the second data. In an exemplary embodiment of method 1500, the correlation indicates how impedance can change or expected impedance values or ranges for certain charge transfer values or data. In this regard, again, it has been found that impedance values or otherwise measurements of impedance within a human being or otherwise measurements of impedance between electrodes will have statistically significant different values or otherwise will change depending on whether or not the electrodes at issue had been utilized to stimulate tissue or at least variables related to charge transfer associated with those electrodes, all other things being equal. This is not due to a chemical change in the recipient per se (although it could be that the prior stimulation does cause a local change in the chemistry of the fluid) or due to fibrous tissue growth that has occurred that results in the increase in impedance. This is an increase or decrease in impedance resulting from the fact that the electrodes at issue have been utilized or have not been utilized or otherwise how they have been utilized during a significant period of time prior to the impedance measurements all other things being equal.For example, if the same frequency and the same current level and the same pulse width and number of pulses per second or per millisecond delivered by the same to electrodes or what have you are utilized to measure impedance between two or more electrodes, the impedance values can be different depending on whether or not those electrodes were utilized to stimulate tissue during certain periods prior to the impedance measurements.

[0149] Embodiments of method 1500 include utilizing the correlation to develop a database so as to provide a data set that can be utilized to evaluate impedance readings. In this regard, the action of developing a correlation between the first data and the second data need not include clinically interpreting the impedance readings, or even evaluating the impedance readings, at least not with respect to an evaluation that goes beyond assessing whether or not the readings are valid or whether or not the readings make sense, as distinguished from evaluating those readings to ascertain what those readings mean utilizing those readings as a latent variable.

[0150] In an embodiment, method 1500 can be a method of diagnostic impedance testing. This can entail testing for all or a subset of the following “standardised impedance measurements” and interpretation routines.

[0151] For example, the method can include avoiding / preventing any charge or at least any substantial charge from passing through one or more pertinent electrodes for a period of time, either predetermined or otherwise determined during the process, such as, for example, within a temporal period that is less than, greater than and / or equal to 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500, 1750 or 2000 minutes or 34, 35, 40, 45 50, 55, 60, 65, 70, 75, 80, 85 or 90 hours or more or any value or range of values therebetween in 0.01 minute increments. Then, following this period, impedance measurement(s) are taken once or at defined intervals for one or more or all electrodes, such as electrodes 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 and / or 22 or any number or range of numbers therein of an electrode array (electrode 1 being the most basil electrode, electrode 22 being the most apical electrode, with increasing value from basil to apical), and / or any other electrode. The intervals can be equally spaced apart or variable. Thre can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, 25, 30, 35, 40, 45 or 50 or more or any value or range of values therebetween in 1 increment of impedance readings for any one or more or all of the electrodes, and the number need not be the same for each electrode. The idea here is that the impedance measurements will be for the non-use scenario or the nostimulation scenario (and thus will likely be higher relative to that which would otherwise be the case). And briefly, as an aside, other control variables can also be put in place, such as the recipient’s diet or exercise regime or sleep routine or medicament regime or sun exposure regime or stress exposure, etc., during all or part of the temporal periods that are applicable to the method actions detailed herein.

[0152] In any event, in view of this, figure 17 presents an exemplary algorithm for an exemplary method 1700, including method action 1710, which includes taking impedance measurements after an effective temporal period of no stimulation and / or minimal stimulation, such as the periods just detailed above.

[0153] The data associated with method action 1710 is stored or otherwise maintained for later use, such as use in the database detailed herein. Method 1700 further includes method action 1720, which can include passing a defined amount of charge through one or more or all of the electrodes within an effective temporal period, whether such be predetermined or determined during the process and methods action 1730, which includes taking one or more impedance measurements after the amount of charge has been passed. In an embodiment, the defined amount of charge passed by a given electrode can be less than, greater than and / or equal to 0.1, 0.25, 0.5, 75, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1050, 1100, 1150, 1200, 1250 or 1300 nC or any value or range of values therebetween in 0.05 increments nC or pC / cm2, and the numbers need not be the same, but are presented herein in this manner for textual economy, and the values can be variable depending on the tissue (0.1 nC may be meaningless for a cochlear implant, but meaningful for a retinal implant, etc.). In an embodiment, the temporal period can be less than, greater than and / or equal to 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500, 1750 or 2000 minutes or 34, 35, 40, 45 50, 55, 60, 65, 70, 75, 80, 85 or 90 hours or more or any value or range of values therebetween in 0.01 minute increments. The defined amount of charge that is passed can be passed during a continuous temporal period or at intervals within aforementioned time periods, periodically or randomly. Indeed, it could be that the charge that is passed could be charge passed for hearing stimulation purposes for example, in the amount of charge passed is monitored and then when the desired amount of charge is passed, stimulation stops and the impedance measurements are taken. Conversely, the charge that is passed could be the charge that is regimented and otherwise controlled in anexacting manner. Indeed, the charge that is passed could be passed using a set current level, such as the amplitude of the biphasic pulse, a set pulse width and / or a set pulse rate, and / or a set frequency. This can have utilitarian value with respect to obtaining a known quantity and / or quality of charge and other data so that such can be correlated with the impedance measures taken in method action 1730, for such impedance measures can be taken in accordance with the teachings detailed herein.

[0154] The data associated with method action 1720 and 1730 are stored or otherwise maintained for later use, such as use in the database detailed herein.

[0155] Embodiments include executing one or more or all of the actions of method 1700 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45 or 50 times or more or any value or range of values therebetween in one increment or however many times can be utilitarian with respect to developing a utilitarian set of data. Note that in an embodiment, the method actions or at least some of them are repeated until a measured impedance change between one or more or all of the electrodes or any of the numbers detailed herein between method action 1710 and method action 1730 is below a threshold, which threshold can be predetermined, which threshold could be a threshold set that is less than, greater than and / or equal to 0.1, 0.15, 0.2, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500, 1750 or 2000 ohms or any value or range of values therebetween in 0.01 ohm increments. This can be a metric that can determine when enough data is “enough.” In an embodiment, the threshold is a threshold that is deemed to fall within the “noise” between impedance measurements that are influenced by prior stimulation and those that are not influenced by prior stimulation. The applied charge may be kept constant or decreased or increased in each iteration.

[0156] Thus, by following method 1700, a database of impedance measurements related to charge data and non-charge data for that matter can be developed which can be utilized to better interpret in a clinical manner the impedance measurements obtained from within a human being.

[0157] It is briefly noted that in an exemplary implementation of method 1700, the impedance data that is obtained in method action 1710 and / or method action 1730 is compared to the appropriate value or range in a databased of diagnostic impedances to determine if the impedance is “normal” or “pathological” for example. This can be done toaccount for the possibility that the impedance measurement s) taken in method actions 1710 and 1730 did not have a valid entry in the “normal impedance” database to which comparison can be made. If the impedance value is “normal, the choice is given to continue the diagnostic measures or to stop whatever method is being undertaken (whether method 1700 or another method). In an embodiment, the impedance change from the first impedance measures in action 1710 to the second impedance measure in action 1730 is calculated and otherwise determined and compared to the appropriate value in the database of “normal impedances” to determine if the impedance change is “normal” or “pathological.”

[0158] Returning back to method 1500, FIG. 16 shows an algorithm for an exemplary method, method 1600, that includes method action 1610, which includes executing at least some of method 1500, such as by way of example only and not by way of limitation, method action 1510 and method action 1520. Method 1600 also includes method action 1620, which includes validating and / or invalidating and / or calibrating the second data based at least in part on the first data. In an exemplary embodiment, this entails validating and / or invalidating and / or calibrating the impedance measurements taken with the electrodes implanted in the human of the first data based on the least one variable. By way of example only and not by way of limitation, method action 1520 can be executed in the normal course of impedance measuring, and method action 1510 can include accessing stored data in the implant and / or the external component and / or a remote component relating to the charge transfer for the one or more electrodes. This data could be data that was recorded or otherwise logged for a period before, such as the prior one hour or two hour or three hours or more or whatever temporal period can have utilitarian value prior to measuring impedance of the electrodes upon which the second data is based. In an exemplary embodiment, the first data can then be compared to previously correlated data that correlates charge transfer data to impedance measurements or values, which data could be obtained from the aforementioned database detailed above, which database could have been developed in accordance with the teachings detailed herein. In any event, method action 1620 can include identifying impedance values or the range of impedance values that are correlated to a given set of data for a given charge transfer data set which corresponds to that of the first data, and then comparing the impedance values for the second data or data based on the impedance values for the second data to impedance values or data based on the impedance values in the database that are correlated to the charge values in the database that correspond to the charge values of the first data. If the impedance values of the second data fall within a range or otherwise aresufficiently close to values in the database, the impedance measurements can be validated, and if they are not close or otherwise fall outside of the range, they would be invalidated. Method action 1620 also includes as an alternative action calibrating the second data. In this exemplary embodiment, it could be that the database includes a function or weighting data that is to be applied based on the charge values of the first data. For example, if the first data indicates that no charges been passed for the past eight hours for example the impedance values could be weighted by a value between 0.25 and 0.8 for example, to account for the fact that the impedance values would be higher than that which would otherwise be the case because of the stimulation, and then the now calibrated impedance values could be evaluated so as to utilize those impedance values as a latent variable to ascertain other things in accordance with the teachings detailed herein.

[0159] In an embodiment, the action of validating and / or invalidating and / or calibrating is automatically executed by comparing the second data to appropriate impedance value(s) correlated to the obtained at least one variable. In an embodiment, the action of validating and / or invalidating and / or calibrating is automatically executed using a computer system that makes the comparison. In an embodiment, the action of validating and / or invalidating and / or calibrating includes validating the impedance measurement and the method further comprises comparing the validated impedance measurement to a database of impedance values correlated to the at least one variable to determine if the impedance is normal and / or abnormal.

[0160] In an exemplary embodiment, such as where the electrodes are part of a cochlear implant electrode array implanted in the human, the method can further comprise creating in impedance database with the developed correlation, which can also include as broken out items the first data and / or the second data. Consistent with the teachings detailed above, there can be a method of developing this database by also obtaining data based on electrode array entry into a cochlea of the human and populating the database based thereon, obtaining data based on electrode array position in the cochlea of the human and populating the database based thereon, obtaining data based on length of time since the electrode array was implanted and populating the database based thereon and obtaining data based on demographic and health and treatment data pertaining to the human and populating the database based thereon. In an exemplary embodiment, there is a method that includes obtaining access to a database that has one or more or all of the above-noted entries therein,and executing one or more method actions detailed herein in conjunction with data obtained from that database in accordance with the teachings detailed herein.

[0161] Briefly, it is noted that in an exemplary embodiment, the database can include additional data, such as the status of the electrode interface, such as the above-noted cleanliness of the surface of the electrodes, such as the amount of protein and / or cell adhesion thereto, which could be based on latent variables (more on this in a moment), the biology adjacent to the electrode pads such as the cellular composition, density and / or thickness of the fibrous sheath if present. Additional data could be related to or otherwise indicative of the perilymph composition, such as the concentration and / or type of proteins and / or other organic constituents and / or the health of neural structures, such as, for example, the spiral ganglion cell population and / or the integrity of the blood-labyrinth barrier. Data regarding the cochlea seal around the electrode array and / or the health of hair cells or otherwise the cilia in the cochlea and / or other structures of the cochlea can be included in the database.

[0162] Also, it is noted that the database can be based on or correspond to, for example, Microsoft™ Access™ database, for example, and can be run on a personal computer by way of example, with input and search algorithms concomitant with that software package.

[0163] In an embodiment, the amount of cycles or charge passed and / or a number of pulses and / or maximum charge and / or a voltage and / or current level passed through the electrodes until the measured impedance change is below or at one or more of the thresholds can be used to compare to an appropriate value in the “diagnostic impedance” database to characterise the electrode interface and / or the adjacent biology including the composition (cell types such as macrophages, fibroblasts, foreign body giant cells), density, and thickness of the fibrous sheath, the perilymph composition including concentration and type of proteins and other organic constituents. Measuring impedance change over time without passing charge after a defined amount of charge has been applied can be used to characterise the electrode interface and / or the adjacent biology. Embodiments thus include executing one or more of these actions to ascertain the related data and information, which data and / or information can be stored in the aforementioned database.

[0164] Consistent with the teachings above, the database can include data regarding the correlation of the charge required to cause impedance change greater than any one or more of the thresholds detailed herein, or a threshold greater than 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500,1750, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 5500, 6000, 6500, 7000, 8000, 9000, 10000, 11000, 12000, 13000, 14000 or 15000 ohms or greater or any value or range of values therebetween in 1 ohm increments. Also consistent with the teachings detailed above, the database can include any of the correlations detailed herein, or more accurately, data based thereon.

[0165] In an exemplary embodiment, some or all of the information of the database can be saved on the implantable portion of the prosthesis, the external portion of the prostheses, or on a smart device in signal communication there with, or a remote device or a device on the cloud or otherwise accessible to the cloud, etc., consistent with the teachings above. In an exemplary embodiment, any one or of the data detailed herein can be stored on such devices or excluded from storage on such devices unless otherwise noted. Storing such data one the external component for example, could have utilitarian value with respect to having sufficient amount of memory and also enabling real time or at least near real time continuous storage of the collected data, such as the charge transfer data. In an embodiment, this database has access to implement one or more of the teachings detailed herein, as detailed above.

[0166] In an exemplary embodiment, the database corresponds to the diagnostic impedance databased detailed above. This database can be populated based on existing and new clinical impedance data, and can be periodically or continuously updated. The updating can be automated or semiautomated or manually. In an exemplary embodiment, every day or every week or every time the cochlear implant or the remote device that’s in signal communication there with comes into signal communication with a Bluetooth signal, the pertinent data can be uploaded to the cloud or uploaded to a remote device, which can be utilized to populate or expand the database.

[0167] In an exemplary embodiment, the database can define normal impedances and / or pathological impedances in accordance with the teachings detailed herein, such as based on data based on any one or more of the just noted entries into the database.

[0168] In an embodiment, there is a computer system, comprising an input subsystem configured to receive input regarding impedance values inside a person who has received a medical device, an output subsystem a data evaluation subsystem in signal communication with the input subsystem and the output subsystem. In this embodiment, the system is configured to compare the impedance values for the person against a normative databased based on a statistically significant number of individuals to evaluate the input. Theinformation in the database can include any one or more of the data detailed herein and variations thereof, with respect to the particular person (recipient) and / or the statistically significant number of individuals.

[0169] In an embodiment, the data evaluation subsystem is configured to confirm if impedance levels are within normal bounds or outside of expectations based on the comparison. In an embodiment, the system is configured to indicate, based on the comparison, whether a specialist should be consulted to evaluate the person.

[0170] Consistent with the teachings above, in an embodiment, the data evaluation subsystem is configured to use one or more of the following when evaluating the input: manner in which a body cavity is reached by the medical device; insertion depth into a cavity of the medical device; time elapsed since a surgery implanting the medical device; how much stimulation has been applied to tissue by the medical device; when stimulation was applied by the medical device; type of medical device; or whether the medical device has a drug delivery feature.

[0171] In an embodiment, the data evaluation subsystem is an artificial intelligence (Al) arrangement, wherein the Al arrangement is configured to compare the impedance values for the person against the normative databased based on the statistically significant number of individuals to evaluate the input. In an embodiment, the Al subsystem (or a non-AI implementation of the data analysis subsystem) is configured to confirm (automatically) if impedance levels are within normal bounds or outside of expectations based on the comparison.

[0172] Thus, consistent with the teachings above, the system can apply an algorithm comparing the impedances of a particular patient against a normative database of a large number of cases (however many can provide statistically useful / significant or otherwise can enable the teachings herein) to confirm if the impedance levels, whether following surgery or well after surgery implanting the medical device, are within normal bounds or outside of expectations, and in an embodiment, the system can provide an automatic indication that there is utility for more attention or specialist analysis to determine if some intervention is required. An exemplary method includes utilizing this system where the indication indicates more attention is required and the patent has residual hearing and the impedance values were a latent variable due to excessive inflammatory reaction that could have compromised theresidual hearing, and the method preserved at least some, if not all, or at least 50, 55, 60, 65, 70, 75, 80, 85 or 90% or more or any value or range of values therebetween in 1% increments of the residual hearing, such as overall frequencies where residual hearing existed.

[0173] In an embodiment, any one or more of the data detailed herein for the recipient and / or for the statistically significant population is stored in the memory, such as, for example, aetiology, co-morbidities, and / or non-hearing related drug regimes. Embodiments include any data that can have utilitarian value with respect to providing insight from impedance measures can be / is stored in the memory. Further, information / data regarding otosclerosis and / or large vestibular aqueduct aetiologies can be provided, and / or indications of how such can impact impedance values. Dat regarding whether there exists diabetes and / or other diseases that impact electrolytes that can impact impedances can be stored. Drug therapies such as growth hormone treatment can impact impedances, and thus can also be stored in the memory. In an embodiment, the data evaluation subsystem can evaluate data pertaining to any of these data to evaluate the impedance values / data based thereon and provide an indication automatically as to whether or not the recipient / health care professional should seek further attention / further testing.

[0174] In an embodiment, there is data for at least 20, 25, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1200, 1500, 2000 or more cases or any value or range of values therebetween in one case increments. Note that not all instances or otherwise in potentially no instance do these values correspond to statistically significant numbers of individuals that will enable the evaluation of the input. It could be that the collection of individuals that make up the cases are aberrant or it could be that the particular data is sufficiently obscure that additional cases are needed to arrive at statistically significant data. By way of example only and not by way of limitation, it could be that even with 2000 cases, there is not sufficient data to be considered statistically significant with respect to otosclerosis.

[0175] And note also that embodiments that utilize artificial intelligence or otherwise machine learning do not necessarily need statistically significant amounts of data. The systems do not utilize so-called big data. They can, and often, the more data the better, but machine learning algorithms can extract trends or otherwise extract relations on limited amounts of data that might not be extractable utilizing conventional algorithms, or at least not in an economically viable or efficacious manner. Still, embodiments include measuring or otherwise obtaining data, such as any of the data detailed herein, for a sufficient number ofcases and storing such in a database, in a role or modified or weighted or manipulated manner or any manner that can enable the teachings detailed herein that would have utilitarian value, embodiments can include the application of machine learning and / or other artificial intelligence techniques to develop a more refined analysis of the clinical significance of changes following surgery or months or years after surgery in accordance with the teachings detailed herein.

[0176] In an embodiment, the system can be code colocated with a clinician or the like, or otherwise can be accessed by a clinician via a remote server. In an exemplary embodiment, the data that is loaded into the memory or otherwise evaluated by the data evaluation subsystem can be loaded by a clinician or other healthcare professional, such as by manually extracting impedance measurements from the implant or medical device, or having the recipient periodically place the medical device into signal communication with a device that is in signal communication with a communication system, such as the Internet, or a device that can store the data which then in turn is stored into the memory of the system. Impedance measurements can be taken during these times, including while the recipient is at the hospital following surgery for implantation of the medical device or otherwise recovering at the hospital following surgery or otherwise implantation of the device. Note that the recipient could periodically come back to the clinic or healthcare facility to have a professional control the implant to take impedance readings, all of which are some of which can be stored in the memory by the healthcare professional. Again, conversely, remote medicine techniques can be implemented to obtain the data from the implant or the external device or the smart device or a remote device in signal communication therewith. Embodiments thus include storing in the memory of the system impedance measurements taken over the various time frames detailed herein following surgery, where the data stored in the memory is utilized to implement one or more or all of the method actions detailed herein. But note also that data obtained after the healing process or otherwise well after surgery can also be stored in the memory of the system. And in fact, consistent with the teachings above, the memory could be part of the hearing prostheses or part of a system that includes the hearing prostheses, such as a system that includes the external portion of the cochlear implant and a remote device, such as a smart phone, that is in signal communication there with.

[0177] In an embodiment, there is a system, comprising an input subsystem configured to receive input regarding impedance values inside a person who has received a medical device, which could be the back telemetry inductance communication system of the externalcomponent of a cochlear implant that can receive impedance measurement obtained by the implantable portion of the cochlear implant. The system also includes a memory, and an output subsystem. In an exemplary embodiment, the system includes some form of processor configured to process data relating to a physical phenomenon occurring in the environment of the medical device such as a light processor or a sound processor a sound processor of a cochlear implant. In this exemplary embodiment, the memory is in signal communication with the input subsystem and the output subsystem so that the impedance-based data can be stored in the memory and then retrieved from the memory. In this exemplary embodiment, the memory can also include or instead include charge transfer data for stimulation previously provided by the medical device, such as for stimulation applied to tissue to evoke a hearing percept by a cochlear implant. In an exemplary embodiment, the input subsystem can be an electrical circuit, such as a transistor based system or a database system or a logic circuit that can record control commands produced by the sound processor or a component downstream from the sound processor which is utilized by the implant to determine the electrical characteristics of the stimulation output from the electrodes. This role data could be stored in the memory, or a proxy for the role data can be stored in the memory. Any arrangement that can enable the teachings detailed herein to be utilized, such as a proxy for the charge transfer data, that can be stored in memory can be utilized in some exemplary embodiments. Again, consistent with the teachings above, the memory need not necessarily include the data based on the impedance measurements, although such can also be included. In this exemplary embodiment, the utility of the memory is that the charge transfer history can be accessed and evaluated to implement the teachings detailed herein.

[0178] In this regard, the input subsystem and the output subsystem are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system. In this regard, by way of example only and not by way of limitation, when implementing one or more of the methods detailed herein, a clinician can access the memory, whether such be in the medical device prostheses or in a remote device, such as a smart phone in signal communication there with, and then extract the data stored in that memory, which can be the charge transfer data, or any other data that has utilitarian value that can be stored in that memory, which data could be non-transitory data (not in the memory sense but in the holistic sense - the route of entry into the cochlea of the electrode array is non-transitory - the depth of insertion of the electrode array is non-transitory unless there is migration or some other movement - the fact that therecipient has diabetes is non-transitory, etc., or at least not in the medium run - years for example). In any event, in an embodiment, as the recipient uses the medical device, the various data disclosed herein can be stored in the memory and this data can be accessed, or at least some of it, to implement the teachings detailed herein. In this regard, in an exemplary scenario of use of the system, after the cochlea / ear system has stabilized following implantation surgery, the cochlear implant recipient experiences changes, because for example, the recipient can have the device for decades after implantation, and could be subject to ongoing disease processes in their implanted ear, as well as normal human processes such as puberty, menopause or ageing. In an embodiment, the change occurs at least after 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 years after implantation. Some of these will be transient and frequent or infrequent, while others may be more permanent. Some may be insignificant and some may be clinically significant. Here, there is a system can be used / is used to record the history of impedances and other measures, and there is a system (which could be a separate system), can apply algorithms, including automatically, differentiate between the multiple possible states of these variables, which in turn provides insight to a healthcare professional and / or guidance into the need and / or lack thereof for clinical intervention.

[0179] In an embodiment of the system that includes the medical device / prosthesis (the remote device, such as a smart phone, is not part of the medical device, but can be part of a system that includes such).

[0180] In an embodiment, there is charge transfer data that is stored in the memory from stimulation that occurred at least 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125 or 150 or more hours ago or from a time from which at least some of the data in the memory is uploaded or otherwise transferred to another system, such as an analysis and / or interpretation system, or any value or range of values therebetween in 1 minute increments, where this charge transfer data corresponded to charge transferred to the recipient through the electrodes, such as the electrodes of the cochlear implant electrode array, whether that be in totality or for individual electrodes or groups of electrodes (any disclosure herein of charge transfer data can be related to one or more or all of the electrodes of the implant in the interest of textual economy) and / or the memory includes state information related to the cochlear implant and / or health information related to a recipient of the cochlear implant. Again, consistent with the teachings herein, this information can be accessed for evaluation purposes and / or clinical interpretation purposes.

[0181] In an embodiment, the system is configured to automatically evaluate the charge transfer data and based on the evaluation, automatically execute impedance measuring based on the evaluation and / or automatically avoid execution of impedance measuring based on the evaluation. In this regard, as noted above, embodiments include executing impedance measurements after a certain amount of charge has been applied and / or in a scenario where no stimulation has been applied by one or more electrodes. Accordingly, there are devices that are configured to take impedance measurements under circumstances and avoid doing so under others or otherwise not take impedance measurements under other circumstances, and these routines are not permanent in some embodiments. In this regard, it could be that impedance measurements are desired after a period of nonuse, and then in other instances, impedance measures are desired after a period of use. Embodiments are such that the system is configured to store data based on impedance measurements in correlation with the charge transfer data. Of course, the data based on impedance measurements could be stored in isolation from any charge transfer data that is stored in the memory.

[0182] In an embodiment, the system is configured to utilize a deactivated electrode of an electrode array to execute impedance measuring. In an embodiment, the system is configured to autonomously apply a predefined amount of charge and / or charge density in a controlled manner and the system is configured to measure impedance(s) in controlled temporal proximity to the application of the predefined amount(s). In this regard, consistent with the teachings above, impedance values and measurements can be made in coordination with specific amounts of charge and charge densities or other stimulation scenarios. Accordingly, in an embodiment, there is a system that enables such, that is, without direct control by a clinician or the user, etc., although in other embodiments, direct control by a human is the only way that such can occur, and in other embodiments, the system is configured for both such initiations.

[0183] In an embodiment, the system is a cochlear implant. In an embodiment, the system includes a cochlear implant and a remote device in signal communication with the cochlear implant, where the memory is in one or both (in which case there are two memories) devices.

[0184] As noted above, clinicians typically see recipients for a check-up on some regularly (e.g. every 12 months) at which impedances are usually taken at the beginning of a session as a check on the status of the device. Embodiments can instead or in addition to this include “downloading” data from the memory of the system. This can enable the clinician to see transient impedance changes recorded in the memory. And of course the data can bedownloaded or otherwise accessed from the memory without the recipient going into see the clinician, such as by way of example, by remote telemedicine or automated or semiautomated scheduled or unscheduled data transfers to the cloud for example. Embodiments thus permit a clinician to see a significant change in state for the recipient that might otherwise have been messed if impedance measurements were limited to only those when the recipient was physically co-located or otherwise in signal communication with the clinician.

[0185] Embodiments include a system configured to monitor and store records of impedances and other measures such as electrocochleography, on some regular basis between clinic visits, and also store historical results and / or aetiology, stimulation data logs, and / or electrode array insertion depth.

[0186] Embodiments include a system and / or a device in which some of the methods / and functions detailed herein can be implemented. It is noted that there can be a wide variety of data (input data) collection techniques and / or acquisition techniques, whether the data be utilized for the methods detailed herein with respect to interpreting and / or analyzing and / or developing the data to train the learning algorithm’s detailed herein. Such can entail the utilization of a smart phone, a personal computer, a landline phone, etc. In this regard, in an exemplary embodiment, the data can be obtained from remote locations and analyzed at a different location. It is also noted that a wide variety of data output utilization or transfer techniques can be utilized. By way of example only and not by way of limitation, in an exemplary embodiment, some of the teachings detailed herein can be utilized to remotely conduct at least portions of the method.

[0187] Fig. 18 presents a functional schematic of a system with which some of the teachings detailed herein and / or variations thereof can be implemented. In this regard, FIG. 18 is a schematic diagram illustrating one exemplary arrangement in which a system 1206 can be used to execute one or more or all of the method actions detailed herein. In general, in an exemplary embodiment, the system of FIG. 18 can be representative of both the system utilized to develop a model (to train the model) and the system that results from the model, or one or the other, which model can be utilized to implement one or more of the teachings herein (such as evaluations and / or clinical interpretations - more on this below).

[0188] System 1206 will be described, at least in part, in terms of interaction with a clinician and / or a recipient, although these terms are used as a proxy for any pertinent subject to which the system is applicable (e.g., the subjects used to train a DNN, the subjects utilized tovalidate the trained DNN / the professional that controls the training, the subjects and / or clinicians / professionals to which one or more of the methods are applicable, etc.). In an exemplary embodiment, system 1206 is a clinician controlled system, while in other embodiments it is a recipient controlled system, while in other embodiments, it is a remote controlled system. In an exemplary embodiment, system 1206 can correspond to a remote device and / or system, which, as detailed above, can be a portable handheld device (e.g., a smart device, such as a smart phone), and / or can be a personal computer, etc.

[0189] In an exemplary embodiment, system 1206 can be a system having additional functionality according to the method actions detailed herein. In the embodiment illustrated in FIG. 11, a remote device can be connected to system 1206 to establish a data communication link between a remote device, such as a remote computer and / or a smart phone, etc., and system 1206. System 1206 is thereafter bi-directionally coupled by a data communication link with a remote device in some embodiments. Any communications link that will enable the teachings detailed herein that will communicably couple the implant and system can be utilized in at least some embodiments.

[0190] System 1206 can comprise a system controller 1212 (a processor or chip(s) or any of the teachings herein) as well as a user interface 1214. In an embodiment, the controller 1212 is the data evaluation subsystem. Controller 1212 can be any type of device capable of executing instructions such as, for example, a general or special purpose computer, a handheld computer (e.g., personal digital assistant (PDA)), digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), firmware, software, and / or combinations thereof. As will be detailed below, in an exemplary embodiment, controller 1212 is a processor or a chip or a chipset, or circuitry specialized to execute one or more of the actions / functionalities herein. Controller 1212 can further comprise an interface for establishing the data communications link 1208 the remote device (again, which is a proxy for any device that can enable the methods herein). In embodiments in which controller 1212 comprises a computer, this interface may be, for example, internal or external to the computer. For example, in an exemplary embodiment, system 1206 and cochlear implant may each comprise a USB, FireWire, Bluetooth, Wi-Fi, or other communications interface through which data communications link may be established. Controller 1212 can further comprise a storage device for use in storing information. This storage device can be, for example, volatile or non-volatile storage, such as, for example,random access memory, solid state storage, magnetic storage, holographic storage, etc., and can store any one or more of the data elements / information pieces detailed herein.

[0191] User interface 1214 can comprise a display 1222 and an input interface 1224 (which, in the case of a touchscreen of the portable device, can be the same). Display 1222 can be, for example, any type of display device, such as, for example, those commonly used with computer systems. In an exemplary embodiment, element 1222 corresponds to a device configured to visually display a plurality of words to the recipient and / or professional.

[0192] Input interface 1224 can be any type of interface capable of receiving information from a recipient and / or professional, such as, for example, a computer keyboard, mouse, voice-responsive software, touchscreen (e.g., integrated with display 1222), microphone (e.g., optionally coupled with voice recognition software or the like) retinal control, joystick, and any other data entry or data presentation formats now or later developed. It is noted that in an exemplary embodiment, display 1222 and input interface 1224 can be the same component, e.g., in the case of a touch screen). In an exemplary embodiment, input interface 1224 is a device configured to receive input from the recipient and / or professional indicative of a choice of one or more of the plurality of words presented by display 1222.

[0193] It is noted that in at least some exemplary embodiments, the system 1206 is configured to execute one or more or all of the method actions detailed herein, where the various sub-components of the system 1206 are utilized in their traditional manner relative to the given method actions detailed herein.

[0194] In an exemplary embodiment, the system 1206, detailed above, can execute one or more of the actions detailed herein and / or variations thereof automatically, at least those that do not require the actions of a recipient and / or professional.

[0195] While some embodiments have been described in terms of the portable handheld device obtaining the data, either directly from the recipient and / or from the professional and performing a given analysis, as noted above, in at least some exemplary embodiments, the data can be obtained at a location remote from one or more of the people using the system. In such an exemplary embodiment, the system 1206 can thus also include the remote location (e.g., clinic).

[0196] In this vein, it is again noted that the schematic of FIG. 18 is functional. In some embodiments, a system 1206 is a self-contained device (e.g., a laptop computer, a smart phone, etc.) that is configured to execute one or more or all of the method actions detailedherein and / or variations thereof. In an alternative embodiment, system 1206 is a system having components located at various geographical locations. By way of example only and not by way of limitation, user interface 1214 can be located with the clinician or recipient (e.g., it can be the portable handheld device) and the system controller (e.g., processor) 1212 can be located remote from the professional and / or the recipient. By way of example only and not by way of limitation, the system controller 1212 can communicate with the user interface 1214, and thus the portable handheld device, via the Internet and / or via cellular communication technology or the like. Indeed, in at least some embodiments, the system controller 1212 can also communicate with the user interface 1214 via the Internet and / or via cellular communication or the like. Again, in an exemplary embodiment, the user interface 1214 can be a portable communications device, such as, by way of example only and not by way of limitation, a cell phone and / or a so-called smart phone. Indeed, user interface 1214 can be utilized as part of a laptop computer or the like. Any arrangement that can enable system 1206 to be practiced and / or that can enable a system that can enable the teachings detailed herein and / or variations thereof to be practiced can be utilized in at least some embodiments.

[0197] Embodiments can include the use of impedance measures in a standard fashion wherein all the electrodes of the electrode array (or the ones that are not deactivated) are part of the stimulation therapy and also monitored for impedance. Embodiments include electrodes that are specially set aside for monitoring impedance without being part of the normal stimulation regime. These could be “never used” electrodes, and cannot be used for simulation in some embodiments, or otherwise are not in signal communication with any channel. These impedance dedicated electrodes could be located on the carrier of the electrode array. However, note that in an embodiment, the “dedicated electrodes” can also be configured to apply stimulation, or at least the charges / charge densities detailed herein, so as to enable the teachings herein (for example, an electrode could be configured to provide sufficient output so as to stimulate tissue, but such would not be connected to a specific channel of the cochlear implant that converts sound into stimulus based on the sound to evoke a hearing percept - a hearing percept could be evoked, but it is not part of the design of the cochlear implants to do so - this is distinguished from, for example, an electrode that is part of the channel that is deactivated or otherwise where the channel has been rerouted to provide stimulation from another electrode relative to that which would normally be the case).

[0198] Specific electrode contacts could be included on the electrode array specifically for impedance monitoring without being intended for normal stimulation. Electrode contacts intended for impedance monitoring could be placed at specific locations on the electrode array for particular purposes. For example:• Some electrodes could be placed more proximal to the most basal stimulation contact to measure tissue growth at the opening to the cochlea, i.e., in the vicinity of the cochleostomy or round window opening. These electrodes could be used to determine the extent or density of tissue growth. They could also assist in determining the insertion depth of the electrode array during surgery, or perioperatively, or any time after surgery.• Some electrodes could be placed at different points along the electrode array to measure if the nature of tissue growth is similar along the length of the array. These electrodes could also be used to determine if there is a progression of tissue growth along the array. Typically this would start at the base and move apically, though it is also possible that tissue growth could start at a point of intra-operative trauma in the middle of the array and extend from there.• It is also possible to place specific electrodes around the circumference of the array allowing determination of the origin of tissue growth on the medial side or lateral side of the array.

[0199] Such embodiments can have utilitarian value (where electrodes specifically set aside for measurement), such as, for example:• Determination of an unusual trend or degree of impedance increase can allow a clinician to consider medication to arrest the trend. This could help to avoid loss of residual hearing or simply prevent an avoidable high impedance which can result in higher power consumption or an out-of-compliance condition.• By reserving electrodes specifically for impedance measurement allows one to set a known level of conditioning of the electrodes, potentially improving the specificity of the measurements in comparison to normal stimulation electrodes which are subject to variations in levels and degrees of stimulation due to different mapping by clinicians, different usage patterns of the recipient, and different levels and types of sound to which the recipient is subject.• The electrodes could be physically spaced and / or patterned geometrically to provide for different sensitivities to detect impedance changes.• The electrodes could be made of different materials or surface geometries to provide for different sensitivities to various cell types.

[0200] Embodiments include using any of the just describe electrodes to implement any one or more or all of the method actions herein providing that the art enables such.

[0201] At least some exemplary embodiments according to the teachings detailed herein utilize advanced learning signal processing techniques, which are able to be trained or otherwise are trained to detect higher order, and / or non-linear statistical properties of signals.An exemplary signal processing technique is the so called deep neural network (DNN). At least some exemplary embodiments utilize a DNN (or any other advanced learning signal processing technique) to process a signal representative of captured sound, which processed signal is utilized to evoke a hearing percept. At least some exemplary embodiments entail training signal processing algorithms to process signals indicative of captured light or the reflected sonic energy and / or radio frequency energy. That is, some exemplary methods utilize learning algorithms or regimes or systems such as DNNs or any other system that can have utilitarian value where that would otherwise enable the teachings detailed herein to analyze the data captured by the electrodes. Some embodiments use an expert system.

[0202] A “neural network” is a specific type of machine learning system, and embodiments include using a neural network to analyze the data captured by the sensor. Any disclosure herein of the species “neural network” constitutes a disclosure of the genus of a “machine learning system.” While embodiments herein focus on the species of a neural network, it is noted that other embodiments can utilize other species of machine learning systems accordingly, any disclosure herein of a neural network constitutes a disclosure of any other species of machine learning system that can enable the teachings detailed herein and variations thereof. To be clear, at least some embodiments according to the teachings detailed herein are embodiments that have the ability to learn without being explicitly programmed. Accordingly, with respect to some embodiments, any disclosure herein of a device or system constitutes a disclosure of a device and / or system that has the ability to learn without being explicitly programmed, and any disclosure of a method, at least one that constitutes analysis, constitutes actions that results in learning without being explicitly programmed for such.

[0203] It is noted that in at least some exemplary embodiments, the DNN or the product from machine learning, etc., is utilized to achieve a given functionality and / or method action as detailed herein. In some instances, for purposes of linguistic economy, there will be disclosure of a device and / or a system that executes an action or the like, and in some instances structure that results in that action or enables the action to be executed. Any method action detailed herein or any functionality detailed herein or any structure that has functionality as disclosed herein corresponds to a disclosure in an alternate embodiment of a DNN or product from machine learning, etc., that when used, results in that functionality, unless otherwise noted or unless the art does not enable such.

[0204] Accordingly, embodiments can use a DNN or a product from machine learning or other types of artificial intelligence systems to analyze the data based on data from the electrodes (which could be the data directly from the sensors, or data compiled based on the data from the sensors).

[0205] In an exemplary embodiment, there is a product of machine learning of analyzing the various data herein, and that product is a chip that is fabricated based on the results of machine learning. In an exemplary embodiment, the product is a neural network, such as a deep neural network (DNN). The product can be based on or be from a neural network. In an exemplary embodiment, the product is code. In an exemplary embodiment, the product is a logic circuit that is fabricated based on the results of machine learning. The product can be an ASIC (e.g., an artificial intelligence ASIC). The product can be implemented directly on a silicon structure or the like. Any device, system and / or method that can enable the results of artificial intelligence to be utilized in accordance with the teachings detailed herein, such as in a hearing prosthesis or a component that is in communication with a hearing prosthesis, can be utilized in at least some exemplary embodiments. Indeed, as will be detailed below, in at least some exemplary embodiments, the teachings detailed herein utilize knowledge / information from an artificial intelligence system or otherwise from a machine learning system.

[0206] Exemplary embodiments include utilizing a trained neural network to implement or otherwise execute at least one or more of the method actions detailed herein, and thus embodiments include a trained neural network configured to do so. Exemplary embodiments also utilize the knowledge of a trained neural network / the information obtained from the implementation of a trained neural network to implement or otherwise execute at least one or more of the method actions detailed herein, and accordingly, embodiments include devices, systems and / or methods that are configured to utilize such knowledge. In some embodiments, these devices can be processors and / or chips that are configured utilizing the knowledge. In some embodiments, the devices and systems herein include devices that include knowledge imprinted or otherwise taught to a neural network. The teachings detailed herein include utilizing machine learning methodologies and the like to establish sensory prosthetic devices or supplemental components utilized with sensory prostatic devices (e.g., a smart phone), implement at least some of the teachings herein. By way of example, additional testing can be executed, and the results of the testing can be provided to a neural network foranalysis, and the product of that can be used to ascertain whether or not to implement a treatment regime.

[0207] In exempl ry embodiment, there can be a component that can be a processor or a chip “programmed” or having access to programming to execute one or more of the functions herein.

[0208] And to be clear, in an exemplary embodiment, there are products of machine learning algorithms (e.g., the code from the trained machine learning algorithm) that are included in any one or more of the systems / subsystems detailed herein, that can be utilized to analyze any of the data obtained or otherwise available disclosed above that can be utilized or otherwise is utilized to evaluate the utilitarian value of any one or more of the implants detailed herein. This can be embodied in software code and / or in computer chip(s) that are included in the system(s).

[0209] Embodiments can include a system and / or simply an embodiment that includes a non- transitory computer readable medium having recorded thereon, a computer program for executing at least a portion of a method, the computer program including code for executing any one or more of the method actions and / or functionalities detailed herein. Thus, any disclosure herein of a method action or functionality corresponds to a disclosure of a non- transitory computer readable medium having programed thereon code to execute one or more of those actions and also a product to execute one or more of those actions.

[0210] Embodiments include any functionality disclosed herein and / or method action disclosed herein being executed by a computer chip, a processor, software, logic circuitry and / or electronics, and all are not mutually exclusive. Any circuit that can enable the teachings herein can be used providing that the art enables such. Thus, in the interests of textual economy, and disclosure herein of a functionality of an article of manufacture corresponds to any one or more of the aforementioned structures being configured to execute such and otherwise for such, and the same is for any method action disclosed herein, where any such action corresponds to a disclosure of any one or more of the aforementioned structures being configured to execute such and otherwise for such.

[0211] In some embodiments, a neural network, such as a DNN, is used to directly interface to the input into the systems / devices detailed above, and process this input via its neural net, and determine the information detailed above. The network can be, in some embodiments, either a standard pre-trained network where weights have been previously determined (e.g.,optimized) and loaded onto the network, or alternatively, the network can be initially a standard network, but is then trained to improve specific recipient results based on outcome oriented reinforcement learning techniques.

[0212] Any disclosure herein of a processor corresponds to a disclosure in an embodiment of a non-processor device or a combined processor-non-processor device where the nonprocessor is a result of machine learning. Embodiments can include a link from the cloud to a clinic to pass information back and forth, enabling the remote processing noted above and / or enabling the obtaining of additional data for retraining purposes. Information can be uploaded to the cloud to the clinic, where the information can be analyzed. Another exemplary system includes a smart device, such as a smart phone or tablet, etc., that is running a purpose built application to implement some of the teachings detailed herein. Any disclosure herein of a processor corresponds to a disclosure of a non-processing device, or includes non-processing devices, such as a chip or the like that is a result of a machine learning algorithm or machine learning system, etc.

[0213] Reference herein is frequently made to the recipient of a hearing prosthesis. It is noted that in at least some exemplary embodiments, the teachings detailed herein can be applicable to a person who is not the recipient of a hearing prosthesis. Accordingly, for purposes of shorthand, at least some exemplary embodiments include embodiments where the disclosures herein directed to a recipient correspond to a disclosure directed towards a person who is not a recipient but instead is only hard of hearing or otherwise has a hearing ailment and is contemplating obtaining a hearing assistance device.

[0214] Any method action and / or functionality disclosed herein where the art enables such corresponds to a disclosure of a code from a machine learning algorithm and / or a code of a machine learning algorithm and / or a product of machine learning for execution of such. Still as noted above, in an exemplary embodiment, the code need not necessarily be from a machine learning algorithm, and in some embodiments, the code is not from a machine learning algorithm or the like. That is, in some embodiments, the code results from traditional programming. Still, in this regard, the code can correspond to a trained neural network. In an embodiment, the trained neural network can be utilized to provide (or extract therefrom) an algorithm that can be utilized separately from the trainable neural network. In one embodiment, there is a path of training that constitutes a machine learning algorithm starting off untrained, and then the machine learning algorithm is trained and “graduates,” or matures into a usable code - code of trained machine learning algorithm. With respect toanother path, the code from a trained machine learning algorithm is the “offspring” of the trained machine learning algorithm (or some variant thereof, or predecessor thereof), which could be considered a mutant offspring or a clone thereof. That is, with respect to this second path, in at least some exemplary embodiments, the features of the machine learning algorithm that enabled the machine learning algorithm to learn may not be utilized in the practice some of the method actions, and thus are not present the ultimate system. Instead, only the resulting product of the learning is used.

[0215] And to be clear, in an exemplary embodiment, there are products of machine learning algorithms (e.g., the code from the trained machine learning algorithm) that are included in any one or more of the systems / subsystems detailed herein, that can be utilized to analyze any of the data obtained or otherwise available disclosed above that can be utilized or otherwise is utilized to evaluate the data obtained herein. This can be embodied in software code and / or in computer chip(s) that are included in the system(s).

[0216] An exemplary system includes an exemplary device / devices that can enable the teachings detailed herein, which in at least some embodiments can utilize automation. That is, an exemplary embodiment includes executing one or more or all of the methods and / or functionalities detailed herein and variations thereof, at least in part, in an automated or semiautomated manner using any of the teachings herein. Conversely, embodiments include devices and / or systems and / or methods where automation is specifically prohibited, either by lack of enablement of an automated feature or the complete absence of such capability in the first instance.

[0217] At least some of the actions herein can be practiced and otherwise represented by an algorithm where circuitry receives the input (embodied in an analogue or a digital signal), where the input suite converts the “physical” input into electronic signals using analog to digital converters for example, or in the case of the input suite corresponding to an Internet server, receives the digital signal from a remote location, and the digital data is stored in a memory and / or received by the electronics. The electronics, which is a result of the machine learning, takes the digital signal and deconstructs the digital signal to evaluate properties, and then, using its “knowledge” from its training, provides an output.

[0218] It is further noted that any disclosure of a device and / or system detailed herein also corresponds to a disclosure of otherwise providing that device and / or system and / or utilizing that device and / or system.

[0219] It is also noted that any disclosure herein of any process of manufacturing or providing a device corresponds to a disclosure of a device and / or system that results therefrom. Is also noted that any disclosure herein of any device and / or system corresponds to a disclosure of a method of producing or otherwise providing or otherwise making such.

[0220] An exemplary system includes an exemplary device / devices that can enable the teachings detailed herein, which in at least some embodiments can utilize automation, as will now be described in the context of an automated system. That is, an exemplary embodiment includes executing one or more or all of the methods detailed herein and variations thereof, at least in part, in an automated or semiautomated manner using any of the teachings herein.

[0221] Any embodiment or any feature disclosed herein can be combined with any one or more or other embodiments and / or other features disclosed herein, unless explicitly indicated and / or unless the art does not enable such. Any embodiment or any feature disclosed herein can be explicitly excluded from use with any one or more other embodiments and / or other features disclosed herein, unless explicitly indicated that such is combined and / or unless the art does not enable such exclusion.

[0222] Any function or method action detailed herein corresponds to a disclosure of doing so an automated or semi-automated manner.

[0223] While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.

Claims

CLAIMSWhat is claimed is:

1. A method, comprising: obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period; obtaining second data, the second data being data based on impedance measurements from inside the human during a second temporal period; and clinically interpreting the second data based at least in part on the first data as a historical baseline.

2. The method of claim 1, further comprising: determining a temporal difference between the first temporal period and the second temporal period; and clinically interpreting the second data based on the determined difference.

3. The method of claims 1 or 2, further comprising: determining a time from an implantation surgery; and clinically interpreting the second data based on the time from the implantation surgery.

4. The method of claims 1, 2 or 3, wherein: the medical device is a cochlear implant electrode array; there is an increase in impedance between the first temporal period and the second temporal period; the method further comprises determining an insertion depth of the electrode array; and the action of clinically interpreting the second data includes clinically interpreting the second data based at least in part on the insertion depth of the electrode array.

5. The method of claims 1, 2, 3 or 4, wherein: the first temporal period spans at least 6 months; andthe action of clinically interpreting the second data includes utilizing an algorithm to differentiate between clinically significant and clinically insignificant differences in impedance between the second data and the first data.

6. The method of claims 1, 2, 3, 4 or 5, wherein: the impedance measurements of the second data are impedance measurements after an effectively significant period of non-use of a stimulating medical device implanted in the human; and the action of clinically interpreting the second data includes taking into account the effective significant period of non-use.

7. The method of claims 1, 2, 3, 4, 5 or 6, further comprising: determining a drug regime and / or diet of the human; and clinically interpreting the second data based on the drug regime and / or diet of the human.

8. The method of claims 1, 2, 3, 4, 5, 6 or 7, wherein: the human is a recipient of a cochlear implant electrode array; the impedance measurements of the first data are impedance measurements for a prediseased ear system of the human; and the impedance measurements of the second data are impedance measurements for a post and / or current diseased ear system of a cochlea.

9. The method of claims 1, 2, 3, 4, 5, 6, 7 or 8, wherein: the human is a recipient of a cochlear implant electrode array; the impedance measurements of the first data are impedance measurements for a steady-state environment; and the impedance measurements of the second data are impedance measurements after the stead-state environment has been disrupted.

10. The method of claims 1, 2, 3, 4, 5, 6 or 7, further comprising at least one of:(a) determining a life-state of the recipient;(b) determining a temporal proximity to a statistically significant period of non-use relative to the impedance measurements during the second temporal period;(c) determining a status of an ongoing disease process in the recipient; or (c)determining a sleep cycle of the human relative to the second temporal period; and clinically interpreting the second data based at least in part on one or more of “a,” “b,” “c” or “d ”11. A method, comprising: obtaining first data, the first data including impedance measurements from inside a human during a first temporal period; obtaining second data, the second data including stimulation history of one or more electrodes of an implanted medical device for second temporal period before the first temporal period; and evaluating the first data based at least in part on the second data.

12. The method of claim 11, wherein: the stimulation history includes at least one of whether or when the one or more electrodes has been used for tissue stimulation.

13. The method of claims 11 or 12, wherein: the stimulation history includes data based on a feature relating to how much stimulation was applied by the one or more electrodes over a given period of time.

14. The method of claims 11, 12 or 13, wherein: the medical device is a cochlear implant electrode array; and the method further comprises obtaining third data based on insertion depth of the electrode array and / or whether the electrode array is inserted through a cochleostomy opening or another opening in a cochlea of the human; and the action of evaluating the second data is based at least in part on the third data.

15. The method of claims 11, 12, 13 or 14, wherein: the human is a recipient of a cochlear implant electrode array; the impedance measurements of the first data are impedance measurements for activated electrodes of the cochlear implant electrode array and impedance measurements for de-activated electrodes of the cochlear implant electrode array.

16. The method of claims 11, 12, 13, 14 or 15, wherein: the stimulation history indicates that the one or more electrodes have not been used in a substantial manner to stimulate tissue of the human within 5 hours of when the impedance measurements from inside the human were obtained; and the action of evaluating the first data includes determining that the impedance measurements indicate that the impedances fall within a first range that corresponds to statistical data indicative of normal impedance values even though the impedances measures are higher than a second range that corresponds to statistical data indicative of normal impedance values for a scenario where the stimulation history would otherwise indicate that the one or more electrodes have been used in a substantial manner to stimulate tissue of the human within less than 1 hour of when the impedance measurements from inside the human were obtained.

17. The method of claims 11, 12, 13, 14, 15 or 16, wherein: the stimulation history is based on data automatically obtained by a medical device in relation to the medical device providing stimulation to the human to evoke a macro neural response of the human including data obtained continuously and / or sporadically over a one week period.

18. A system, comprising: an input subsystem configured to receive input regarding impedance values inside a person who has received a medical device; a memory; an output subsystem; and at least one of: a data evaluation subsystem in signal communication with the input subsystem and the output subsystem and the memory, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input; or a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the input subsystem and the output subsystem are in signal communication with thememory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system.

19. The system of claim 18, wherein: the data evaluation subsystem is configured to confirm if impedance levels are within normal bounds or outside of expectations based on the comparison.

20. The system of claims 18 or 19, wherein: the system is configured to indicate, based on the comparison, whether a specialist should be consulted to evaluate the person.

21. The system of claims 18, 19 or 20, wherein the data evaluation subsystem is configured to use one or more of the following when evaluating the input: manner in which a body cavity is reached by the medical device; insertion depth into a cavity of the medical device; time elapsed since a surgery implanting the medical device; how much stimulation has been applied to tissue by the medical device; when stimulation was applied by the medical device; a type of medical device; or whether the medical device has a drug delivery feature.

22. The system of claims 18, 19, 20 or 21, wherein: the system includes the data evaluation subsystem, wherein the data evaluation subsystem is an artificial intelligence (Al) arrangement, wherein the Al arrangement is configured to compare the impedance values for the person against the normative database based on the statistically significant number of individuals to evaluate the input.

23. The system of claim 22, wherein: the Al subsystem is configured to confirm if impedance levels are within normal bounds our outside of expectations based on the comparison.

24. The system of claims 18, 19, 20 or 21, wherein: the system includes the sound processor of the cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previouslyprovided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the input subsystem and the output subsystem are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system.

25. The system of claim 24, wherein: charge transfer data is stored in the memory from stimulation that occurred at least one hour ago; and the memory includes state information related to the cochlear implant and / or health information related to a recipient of the cochlear implant.

26. The system of claim 24, wherein: the system is configured to automatically evaluate the charge transfer data and based on the evaluation, automatically execute impedance measuring based on the evaluation and automatically avoid execution of impedance measuring based on the evaluation.

27. The system of claim 24, wherein: the system is configured to store data based on impedance measurements in correlation with the charge transfer data.

28. The system of claim 24, wherein: the system is configured to utilize a deactivated electrode of an electrode array to execute impedance measuring.

29. The system of claim 24, wherein: the system is configured to autonomously apply a predefined amount of charge and / or charge density in a controlled manner; and the system is configured to measure impedance(s) in controlled temporal proximity to the application of the predefined amount(s).

30. The system of claim 21, wherein the system is the cochlear implant.

31. A method, comprising:obtaining first data based on at least one variable of charge transfer data of electrode(s) implanted in a human; obtaining second data based on at least one impedance measurement taken with the electrode(s); and at least one of developing a correlation between the first data and the second data; or validating and / or invalidating and / or calibrating the second data based at least in part on the first data.

32. The method of claim 31, wherein: the obtained at least one variable originated from a hearing prosthesis and / or an accessory of the hearing prosthesis used by the human.

33. The method of claims 31 or 32, wherein: the at least one variable is based on data that was effectively continuously recorded over a statistically significant temporal period of use of the electrodes.

34. The method of claims 31, 32 or 33, wherein: the at least one variable of the charge transfer data includes at least one of total time of activation of a cochlear implant of which the electrodes are a part, a number of pulses of electrical current applied by the electrodes, pulse width of an electrical current applied by the electrodes, current levels applied by the electrodes or total charge passed through the electrodes.

35. The method of claims 31, 32, 33 or 34, further comprising: validating and / or invalidating and / or calibrating the second data based at least in part on the first data.

36. The method of claim 35, wherein: the action of validating and / or invalidating and / or calibrating is automatically executed by comparing the second data to appropriate impedance value(s) correlated to the obtained at least one variable.

37. The method of claim 36, wherein:the action of validating and / or invalidating and / or calibrating is automatically executed using a computer system that makes the comparison.

38. The method of claim 35, wherein: the action of validating and / or invalidating and / or calibrating includes validating the impedance measurement; and the method further comprises comparing the validated impedance measurement to a database of impedance values correlated to the at least one variable to determine if the impedance is normal and / or abnormal.

39. The method of claims 31, 32, 33, 34, 35, 36, 37 or 38, wherein: the electrodes are part of a cochlear implant electrode array implanted in the human; and the method further comprises: creating an impedance database with the developed correlation; obtaining data based on electrode array entry into a cochlea of the human and populating the database based thereon; obtaining data based on electrode array position in the cochlea of the human and populating the database based thereon; obtaining data based on length of time since the electrode array was implanted and populating the database based thereon; and obtaining data based on demographic and health and treatment data pertaining to the human and populating the database based thereon.

40. The method of claims 31, 32, 33, 34, 35, 36, 37 or 38, wherein the method includes both of developing the correlation between the first data and the second data and validating and / or invalidating and / or calibrating the second data based at least in part on the first data.

41. A non-transitory computer readable medium, comprising: code for obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period; code for obtaining second data, the second data being data based on one or more state conditions; andcode for automatically clinically interpreting the first data based at least in part on the second data.

42. The medium of claim 41, wherein: the human is a recipient of a cochlear implant electrode array; and the state condition is a type of entry through which the electrode array was extended into the cochlea.

43. The medium of claims 41 or 42, wherein: the state condition is a depth of insertion of one or more electrodes into a cavity of the human.

44. The medium of claims 41, 42 or 43, wherein: the state condition is a drug delivering feature of a medical device that is used to acquire the impedance measurements from inside the human.

45. The medium of claims 41, 42, 43 or 44, wherein: the state condition is an activation state and / or a deactivation state of an electrode within the human.

46. The medium of claims 41, 42, 43, 44 or 45, wherein: the first data includes impedance measurements monitored over at least 7 days in the human; the state is a partially healed cochlea in which a cochlear implant electrode array is located, which cochlear implant electrode array caused the need for healing; and the action of clinically interpreting the first data includes determining whether or not the electroneural interface is trending to one of: (1) a normal and / or optimal state or (2) abnormal and / or suboptimal state based, based on a temporal location of a healing process resulting in the partially healed cochlea.

47. The medium of claims 41, 42, 43, 44, 45 or 46, wherein: the impedance measurements are based on measurements made with a cochlear implant having an electrode array located in a cochlea of the human; and the one or more state conditions include one or more of:an insertion depth of the electrode array in a cochlea; whether a portion of the cochlear implant extends through a cochleostomy or round window; whether a temporal period from implantation of a cochlear implant electrode array in a cochlea is within a statistically expected temporal period of healing or outside of the statistically expected temporal period of healing; whether the electrode array is located in a cochlea having a statistically large vestibular aqueduct and / or proximate a middle ear suffering from otosclerosis; or whether the cochlear implant electrode array delivers therapeutic substance to the cochlea.

48. A system, comprising: a GUI and / or a USB and / or wired receiver and / or wireless receiver that receives receive input regarding impedance values inside a person who has received a medical device; a computational device memory; and at least one of: a data evaluation subsystem in signal communication with the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and the, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input and output data indicative of the comparison; or a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and / or a second GUI and / or a second USB and / or a wired transmitter and / or a wireless transmitter are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system.

49. A device and / or system and / or method and / or computer readable medium, wherein least one of: the computer readable medium has recorded thereon code for one or more of the method actions below;the system is configured to execute one or more of the method actions below; the method includes obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period; the method includes obtaining second data, the second data being data based on impedance measurements from inside the human during a second temporal period; the method includes interpreting the second data based at least in part on the first data as a historical baseline; the method includes determining a temporal difference between the first temporal period and the second temporal period; the method includes clinically interpreting the second data based on the determined difference; the method includes determining a time from an implantation surgery; clinically interpreting the second data based on the time from the implantation surgery; the medical device is a cochlear implant electrode array; there is an increase in impedance between the first temporal period and the second temporal period; the method further comprises determining an insertion depth of the electrode array; the action of clinically interpreting the second data includes clinically interpreting the second data based at least in part on the insertion depth of the electrode array; the first temporal period spans at least 6 months; the action of clinically interpreting the second data includes utilizing an algorithm to differentiate between clinically significant and clinically insignificant differences in impedance between the second data and the first data; the impedance measurements of the second data are impedance measurements after an effectively significant period of non-use of a stimulating medical device implanted in the human; the action of clinically interpreting the second data includes taking into account the effective significant period of non-use; the method includes determining a drug regime and / or diet of the human; clinically interpreting the second data based on the drug regime and / or diet of the human; the human is a recipient of a cochlear implant electrode array;the impedance measurements of the first data are impedance measurements for a prediseased ear system of the human; the impedance measurements of the second data are impedance measurements for a post and / or current diseased ear system of a cochlea; the human is a recipient of a cochlear implant electrode array; the impedance measurements of the first data are impedance measurements for a steady-state environment; the impedance measurements of the second data are impedance measurements after the stead-state environment has been disrupted;(a) determining a life-state of the recipient;(b) determining a temporal proximity to a statistically significant period of non-use relative to the impedance measurements during the second temporal period;(c) determining a status of an ongoing disease process in the recipient;(c)determining a sleep cycle of the human relative to the second temporal period; clinically interpreting the second data based at least in part on one or more of “a,” “b,” “c” or “d”; the method includes obtaining first data, the first data including impedance measurements from inside a human during a first temporal period; obtaining second data, the second data including stimulation history of one or more electrodes of an implanted medical device for second temporal period before the first temporal period; evaluating the first data based at least in part on the second data; the stimulation history includes at least one of whether or when the one or more electrodes has been used for tissue stimulation; the stimulation history includes data based on a feature relating to how much stimulation was applied by the one or more electrodes over a given period of time; the medical device is a cochlear implant electrode array; the method further comprises obtaining third data based on insertion depth of the electrode array and / or whether the electrode array is inserted through a cochleostomy opening or another opening in a cochlea of the human; the action of evaluating the second data is based at least in part on the third data; the human is a recipient of a cochlear implant electrode array;the impedance measurements of the first data are impedance measurements for activated electrodes of the cochlear implant electrode array and impedance measurements for de-activated electrodes of the cochlear implant electrode array; the stimulation history indicates that the one or more electrodes have not been used in a substantial manner to stimulate tissue of the human within 5 hours of when the impedance measurements from inside the human were obtained; the action of evaluating the first data includes determining that the impedance measurements indicate that the impedances fall within a first range that corresponds to statistical data indicative of normal impedance values even though the impedances measures are higher than a second range that corresponds to statistical data indicative of normal impedance values for a scenario where the stimulation history would otherwise indicate that the one or more electrodes have been used in a substantial manner to stimulate tissue of the human within less than 1 hour of when the impedance measurements from inside the human were obtained; the stimulation history is based on data automatically obtained by a medical device in relation to the medical device providing stimulation to the human to evoke a macro neural response of the human including data obtained continuously and / or sporadically over a one week period; the system comprises an input subsystem configured to receive input regarding impedance values inside a person who has received a medical device; the system comprises a memory; the system comprises an output subsystem; the system comprises a data evaluation subsystem in signal communication with the input subsystem and the output subsystem and the memory, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input; the system comprises a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the input subsystem and the output subsystem are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system; the data evaluation subsystem is configured to confirm if impedance levels are within normal bounds or outside of expectations based on the comparison;the system is configured to indicate, based on the comparison, whether a specialist should be consulted to evaluate the person; the data evaluation subsystem is configured to use one or more of the following when evaluating the input: manner in which a body cavity is reached by the medical device; insertion depth into a cavity of the medical device; time elapsed since a surgery implanting the medical device; how much stimulation has been applied to tissue by the medical device; when stimulation was applied by the medical device; a type of medical device; whether the medical device has a drug delivery ; the system includes the data evaluation subsystem, wherein the data evaluation subsystem is an artificial intelligence (Al) arrangement, wherein the Al arrangement is configured to compare the impedance values for the person against the normative database based on the statistically significant number of individuals to evaluate the input; the Al subsystem is configured to confirm if impedance levels are within normal bounds our outside of expectations based on the comparison; the system includes the sound processor of the cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the input subsystem and the output subsystem are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system; charge transfer data is stored in the memory from stimulation that occurred at least one hour ago; the memory includes state information related to the cochlear implant and / or health information related to a recipient of the cochlear implant; the system is configured to automatically evaluate the charge transfer data and based on the evaluation, automatically execute impedance measuring based on the evaluation and automatically avoid execution of impedance measuring based on the evaluation; the system is configured to store data based on impedance measurements in correlation with the charge transfer data; the system is configured to utilize a deactivated electrode of an electrode array to execute impedance measuring;the system is configured to autonomously apply a predefined amount of charge and / or charge density in a controlled manner; the system is configured to measure impedance(s) in controlled temporal proximity to the application of the predefined amount(s); the system is the cochlear implant; the method includes obtaining first data based on at least one variable of charge transfer data of electrode(s) implanted in a human; the method includes obtaining second data based on at least one impedance measurement taken with the electrode(s) ; the method includes developing a correlation between the first data and the second data; the method includes validating and / or invalidating and / or calibrating the second data based at least in part on the first data; the method includes the obtained at least one variable originated from a hearing prosthesis and / or an accessory of the hearing prosthesis used by the human; the at least one variable is based on data that was effectively continuously recorded over a statistically significant temporal period of use of the electrodes; the at least one variable of the charge transfer data includes at least one of total time of activation of a cochlear implant of which the electrodes are a part, a number of pulses of electrical current applied by the electrodes, pulse width of an electrical current applied by the electrodes, current levels applied by the electrodes or total charge passed through the electrodes; the method includes validating and / or invalidating and / or calibrating the second data based at least in part on the first data; the action of validating and / or invalidating and / or calibrating is automatically executed by comparing the second data to appropriate impedance value(s) correlated to the obtained at least one variable; the action of validating and / or invalidating and / or calibrating is automatically executed using a computer system that makes the comparison; the action of validating and / or invalidating and / or calibrating includes validating the impedance measurement; the method further comprises comparing the validated impedance measurement to a database of impedance values correlated to the at least one variable to determine if the impedance is normal and / or abnormal;the electrodes are part of a cochlear implant electrode array implanted in the human; the method includes creating an impedance database with the developed correlation; the method includes obtaining data based on electrode array entry into a cochlea of the human and populating the database based thereon; the method includes obtaining data based on electrode array position in the cochlea of the human and populating the database based thereon; the method includes obtaining data based on length of time since the electrode array was implanted and populating the database based thereon; the method includes obtaining data based on demographic and health and treatment data pertaining to the human and populating the database based thereon; the non-transitory computer readable medium includes code for obtaining first data, the first data being data based on impedance measurements from inside a human during a first temporal period; the non-transitory computer readable medium includes code for obtaining second data, the second data being data based on one or more state conditions; the non-transitory computer readable medium includes for automatically clinically interpreting the first data based at least in part on the second data; the human is a recipient of a cochlear implant electrode array; the state condition is a type of entry through which the electrode array was extended into the cochlea; the state condition is a depth of insertion of one or more electrodes into a cavity of the human; the state condition is a drug delivering feature of a medical device that is used to acquire the impedance measurements from inside the human; the state condition is an activation state and / or a deactivation state of an electrode within the human; the first data includes impedance measurements monitored over at least 7 days in the human; the state is a partially healed cochlea in which a cochlear implant electrode array is located, which cochlear implant electrode array caused the need for healing; the action of clinically interpreting the first data includes determining whether or not the electroneural interface is trending to one of: (1) a normal and / or optimal state or (2) abnormal and / or suboptimal state based, based on a temporal location of a healing process resulting in the partially healed cochlea;the impedance measurements are based on measurements made with a cochlear implant having an electrode array located in a cochlea of the human; the one or more state conditions include one or more of: an insertion depth of the electrode array in a cochlea; whether a portion of the cochlear implant extends through a cochleostomy or round window; whether a temporal period from implantation of a cochlear implant electrode array in a cochlea is within a statistically expected temporal period of healing or outside of the statistically expected temporal period of healing; whether the electrode array is located in a cochlea having a statistically large vestibular aqueduct and / or proximate a middle ear suffering from otosclerosis; or whether the cochlear implant electrode array delivers therapeutic substance to the cochlea; the system includes a GUI and / or a USB and / or wired receiver and / or wireless receiver that receives receive input regarding impedance values inside a person who has received a medical device; the system includes a computational device memory; the system includes a data evaluation subsystem in signal communication with the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and the, wherein the system is configured to compare the impedance values for the person against a normative database based on a statistically significant number of individuals to evaluate the input and output data indicative of the comparison; the system includes a sound processor of a cochlear implant, wherein the system is configured to store, in the memory, charge transfer data for stimulation previously provided by the cochlear implant, wherein the cochlear implant is the medical device and wherein the GUI and / or the USB and / or the wired receiver and / or the wireless receiver and / or a second GUI and / or a second USB and / or a wired transmitter and / or a wireless transmitter are in signal communication with the memory so that the received input can be stored in the memory and data stored in the memory can be retrieved from outside the system; the method, system and / or code results in relative higher confidence for the clinician and / or patient through software assisted / computer assisted interpretation of clinical impedances measures, relative to that which would otherwise be the case in the absence of the teachings herein, all other things being equal;the method, system and / or code renders impedance as an objective measure to assess the status quo and / or changes of the electrode array interface and / or biological environment adjacent to the electrodes, relative to that which would otherwise be the case; the method, system and / or code enables impedance as a diagnostic measure for such things as, for example, early detection of inflammatory events and / or pathological foreign body reaction to allow informed intervention / prevention of things such as, loss of residual hearing and / or to protect cochlear health including the SGN population, and such can be improved upon relative to that which would otherwise be the case in the absence of such; the method, system and / or code enable impedance as an objective measure to assess the effectiveness of a drug targeting inner ear related pathologies, such as, for example, suppression of inflammation, reduction of foreign body response; the method, system and / or code enable results where traditional interpretation of the clinical significance of the absolute impedance, or change in impedance, or variation between different contacts on an electrode array, has been in prior evaluations, ad-hoc in clinical practice and such is no longer the case; the method, system and / or code enable implementations where the history of impedances of a specific recipient can be understood and considered when interpreting impedances; the method, system and / or code enable clinicians to utilize the impedance data obtained to infer the integrity and / or status of the cochlear implant and the electroneural interface; the method, system and / or code enable clinicians to look on past impedance measures and display graphs or tables of impedance measures from the past, and in embodiments, such measures are combined with other past measures such as stimulation levels or other diagnostic measures (for example ECochG or NRT); the method, system and / or code utilize algorithms applied to assist with interpretation of the clinical significance of the measures; the method, system and / or code go past / beyond merely measuring and report raw data separately on impedances and other measures and simply relying on clinicians make educated guesses as to the clinical significance of the data; the method, system and / or code enable clinicians and / or data analyzing professionals to gain a more comprehensive understanding of the state of the electroneural interface at a specific electrode or group of electrodes, and / or whether some clinical intervention should or should not be recommended or otherwise acted upon;the method, system and / or code provide insight into the state of the tissue in the inner ear. The information / insight can be used to change (including optimize) simulation strategies and / or selection of medical therapy to treat inner ear conditions such as fibrosis or inflammation; the method includes obtaining a history of impedance measures and comparing a current measurement to past impedances, an analytical system to provide more valuable clinical insight than that which is currently available from a system that only presents raw data; the system can provide information and / or analysis based on the historical context to support clinical interpretation; the method includes comparing impedances and / or other measures after an interior of a cochlea reaches a stable state (e.g., after healing / after tissue growth resulting from the initial trauma of implantation has run its course, etc.); the method includes accounting for changes that can occur less than, greater than and / or equal to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55 or 60 years or any value or range of values therebetween in 1 month increments after implantation; the system is configured to record the history of impedances and / or other measures and applies algorithms to help differentiate between the multiple possible states of these variables, which in turn are used to provide insight and guidance into a need or lack of need for clinical intervention; one or more method actions are implemented in a person who tends to not use their cochlear implant device(s) and thus see levels or impedance changes reflecting their usage patterns (or lack of usage patterns); one or more method actions are implemented in a person who is a bilateral cochlear implant recipient who uses one device substantially more than the other and thus the impedance values are different between the two devices, all other things being equal; methods include accounting for progression of some diseases that impact impedances over the long term, such as, for example, otosclerosis and / or or meningitis, and / or accounting for aetiologies and / or chronic diseases that tend to result in fluctuating impedance and / or drug regimes and / or diet that can affect impedances and / or the presence of air bubbles over a plate electrode that can resulting in temporary high impedances, and / or the occurrence of characteristic degradation and / or or open circuits or short circuits vis-a-vis impedance reading evaluation;any one or more of the metho actions are executed with a cochlear implant electrode array located in a cochlea of a human, wherein the impedance values are values for impedances existing within the cochlea within X hours of the electrode array first entering the cochlea (or within X hours from final placement of the cochlea or within X hours from the end of the closure procedure, or within X hours from the time that the recipient leaves the operating room), wherein X can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 or more, or any value or range of values therebetween in 0.1 increments; the first impedance values are impedance values that existed within 6, 5, 4, 3, 2, or 1 hours of the electrode array first entering the cochlea, concomitant with the teachings above, and the second impedance values are impedance values that existed more than 18 hours and less than 30 hours from the electrode array first entering the cochlea; the first and second impedance values obtained with the cochlear implant electrode array were primarily influenced by the environment surrounding and / or adjacent the electrodes used to measure the first and second impedance values, or otherwise the environment within the cochlea; the first impedance values are impedance values for Z of the first 3, 4, 5, 6, 7, 8, 9, or 10, or any value or range of values therebetween in 1 increment read electrodes of the electrode array, the first of the number of electrodes being the most basal electrode, where Z can be 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10, or any value or range of values therebetween, and can start 1, 2, 3, 4, or 5 read electrodes from the first; the second impedance values are impedance values for any one or more or all of those electrodes (they need not be the same), and the first impedance values are impedance values for Z of a first number of read electrodes of the electrode array, the first of the first number of electrodes being the most basal electrode, and the first number of read electrodes being located in the basal portion of the cochlea and the second impedance values are impedance values for Z of the first number of read electrodes or any one or more or all of the first number and the second impedance values can include other read electrodes not used for the first impedance values; the first impedance values are impedance values for all or a subset of a first number of read electrodes of the electrode array, the first of the first number of electrodes being the most basal electrode, and the first number of read electrodes subtending at least an angle of 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280,290, 300, 310, 320 or 330 degrees or any value or range of values therebetween in 1 degree increments within the cochlea, and in some embodiments, not exceeding 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, or 360 degrees, or any value or range of values therebetween in 1 degree increments within the cochlea and / or the second impedance values are impedance values for all or the subset or another subset of the first number of read electrodes; the most basal first, second, third, fourth, fifth, sixth, and / or seventh read electrode (e.g., read electrodes 1, 2, 3; 1, 2 and 5; or 1 and 6) are excluded from the electrodes used to execute one or more of the method actions herein; the impedance measurements are impedance measurements after an effectively significant period of non-use of a stimulating medical device implanted in the human; the action of clinically interpreting the data includes taking into account the effective significant period of non-use; the method actions are executed with a person who predominantly uses one of two cochlear implants during a given temporal period, or does not utilize his and / or her single cochlear implant (or both for that matter) overnight while sleeping, and / or otherwise chooses to have “off coil time” for whatever reason; impedance readings are higher relative to that which would otherwise be the case if the cochlear implant had been used in the preceding 1 or 5 or 10 or 15 minutes or 30 minutes or one hour or two hours or any value or range of values therebetween in one minute increments before data is collected / the impedance measurements were taken; the methods include taking into account a general baseline / historical data set after the recipient’s condition has stabilized; the impedance measurements of the first data are impedance measurements for a steady-state environment and the impedance measurements of the second data are impedance measurements after the steady-state environment has been disrupted; the time period between the acquisition of the measurements of the first data and the acquisition of the measurements of the second data can be less than, greater than and / or equal to 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 125, 150, 175 or 200 months or more or any value therebetween in one week increments; in a method, a deviation from the baseline occurs or otherwise is identified, and the method further includes evaluating the recipient or otherwise the physiological conditions of the recipient to determine if there is a non-cochlea related cause related (including non-directly cochlea related, which would include diet or drugs for example, although such would the an indirectly cochlea related cause) for such deviation, such as a change in state of the implant or a condition inside the recipient’s body proximate a portion of the implant outside the cochlea for example; the data is data on frequency dependent resistance of a circuit for alternating current; the impedance measurement is measured between any 2 intracochlear electrodes, any intracochlear electrode and any extra cochlear electrode, and any combination of electrode pairs. All impedance modes including conventional multipolar 1, multipolar 2, multipolar 1+2, bipolar, common ground, 4-point and any other possible combination of electrodes to form an electrode pair might be used to take measurements; the method includes taking a series of impedance measures either at the same or changing parameters (current level, pulse width, etc.) at defined time intervals and an equation is fitted to the impedance results and / or using the param eter / constants of this fitted curve for diagnostic purposes; the impedance measures are triggered by an event, the recipient, a carer or health care professional and / or occur automatically at predefined time intervals, and / or when certain circumstances are given such as “coil on” but in a silent environment; one or more electrodes have not been used in a substantial manner to stimulate tissue ofthe human within 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35 or 40 hours or any value or range arise therebetween in one minute increments of when the impedance measurements from inside the human were obtained; the action of evaluating data includes determining that the impedance measurements indicate that the impedances fall within a first range that corresponds to statistical data indicative of normal impedance values even though the impedances measures are higher than a second range that corresponds to statistical data indicative of normal impedance values for a scenario where the stimulation history would otherwise indicate that the one or more electrodes have been used in a substantial manner to stimulate tissue of the human within less than 6, 5, 4, 3, 2, 1, 0.5, 0.25 hours or any value or range of values therebetween in 0.01 hour increments of when the impedance measurements from inside the human were obtained; the lack of stimulation of tissue by the one or more electrodes for a given period of time results in higher impedance values relative to that which would otherwise be the case; the impedance values are so high that even after discounting or otherwise taking into account the fact that the impedance values were obtained after a meaningful and substantial period of nonuse or non-stimulation, the impedance values are still indicative of a problemand / or the impedance values are lower than the range than that would be expected, which indicates that additional testing is needed and / or that there is some form of problem, whether with the human or whether with the medical device; a defined amount of charge passed by a given electrode is less than, greater than and / or equal to 0.1, 0.25, 0.5, 75, 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1050, 1100, 1150, 1200, 1250 or 1300 nC or any value or range of values therebetween in 0.05 increments nC or pC / cm2, and the numbers need not be the same, and the values can be variable depending on the tissue; one or more of the method actions are executed 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 35, 40, 45 or 50 times or more or any value or range of values therebetween in one increment or however many times can be utilitarian with respect to developing a utilitarian set of data; the method actions are repeated until a measured impedance change between one or more or all of the electrodes or any of the numbers that are utilitarian is below a threshold, which threshold can be predetermined, which threshold could be a threshold set that is less than, greater than and / or equal to 0.1, 0.15, 0.2, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25, 30, 45, 60, 90, 120, 200, 250, 300, 350, 400, 500, 600, 650, 700, 750, 800, 850, 900, 950, 1000, 1250, 1500, 1750 or 2000 ohms or any value or range of values therebetween in 0.01 ohm increments; there is charge transfer data that is stored in the memory from stimulation that occurred at least 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 9, 10, 11, 12, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125 or 150 or more hours ago or from a time from which at least some of the data in the memory is uploaded or otherwise transferred to another system, such as an analysis and / or interpretation system, or any value or range of values therebetween in 1 minute increments, where this charge transfer data corresponded to charge transferred to the recipient through the electrodes, such as the electrodes of the cochlear implant electrode array, whether that be in totality or for individual electrodes or groups of electrodes; one or more of the method actions are executed using a trained DNN or other form of artificial intelligence system; or the system includes a trained DNN and / or has access to a trained DNN or other form of artificial intelligence system.

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